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Postpartum Hemorrhage Prevention in Nepal: A Program Assessment

This one-page document summarizes an assessment of Nepal’s national postpartum hemorrhage prevention program. The assessment focused in particular on the advance provision of misoprostol to pregnant women for use during home births and was carried out by Nepal’s Ministry of Health and Population, Gynuity Health Projects, and New ERA. The article on which this summary is based is published in the BMC Pregnancy and Childbirth (Rajbhandari et al. 2017) and is available to download here.

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What Is the Most Effective, Low-Cost Method for Inducing Labor in Women With Pre-Eclampsia?

Pregnant women continue to suffer and die unnecessarily from hypertensive disorders, a leading cause of maternal deaths worldwide. Conditions such as pre-eclampsia and eclampsia (PE/E)—which are unique to pregnancy and the immediate postpartum period—are most often characterized by a rapid and unexpected rise in blood pressure. If not diagnosed and treated promptly, they can lead to seizure, stroke, organ failure as well as maternal and perinatal death.

While treatment with magnesium sulfate and drugs that lower blood pressure can reduce death and disability associated with PE/E, the only definitive way to cure this pregnancy complication is with delivery, preferably vaginal, of the baby. Inducing labor is often a critical component of care for women with pre-eclampsia.

Access the full Blog at Maternal Health Task Force.

Results of a pilot study in the U.S. and Vietnam to assess the utility and acceptability of a multi-level pregnancy test (MLPT) for home monitoring of hCG trends after assisted reproduction

Background: To evaluate the utility and acceptability of using multi-level pregnancy tests (MLPTs) at home to monitor hCG trends following assisted reproductive technology (ART).

Methods: One hundred and four women presenting for ART at either Stanford Medicine Fertility and Reproductive Health Clinic (Stanford, CA) or Hung Vuong Hospital (Ho Chi Minh City, Vietnam) participated in this pilot study. Women were asked to perform the MLPT at home, primarily on days when they were also scheduled to receive standard clinic-based serum hCG testing. These tests were administered up to 6 times over the 6-week period following embryo transfer or intrauterine insemination (IUI). Concordance of serial hCG readings for each time point was assessed by comparing trends in urine MLPT results with trends in serum hCG. Stable or increasing hCG level was interpreted as an indication of a progressing pregnancy, while a declining hCG was interpreted as a lack of established or progressing pregnancy. At study end, all participants were asked about the acceptability and convenience of using the MLPT at home for monitoring hCG trends following ART.

Results: Data from both urine and serum testing are available for 156 of 179 clinic visits (87.2%). There was high concordance of serial trend results between the two types of tests: among the 156 sets of serum and urine hCG data points, 150 (96.2%) showed a matching trend in hCG pattern and 6 (3.8%) resulted in a discordant trend. Seventy-three percent of women reported being satisfied or very satisfied with using the MLPTs at home. Almost all (96.6%) said that the MLPT was easy or very easy to use.
Conclusion: The MLPT offers women and health care providers a client-friendly diagnostic tool to detect very early pregnancy and monitor its progress.

Trial registration: This study was registered on clinicaltrials.gov as NCT01846403 (May 1, 2013), and NCT01919502 (August 5, 2013).

Access the full article at BMC Women’s Health.

  • Topic: Medical Abortion
  • Type: Staff Publications
  • Author: Shochet, T., Comstock, I. A., Ngoc, N.T.N., Westphal, L.M., Sheldon, W.R., Loc, L.T., Blum, J., Winikoff, B., Blumenthal, P.D.
  • Published: August 2017

Improving Care at Delivery for Women with Preeclampsia: Comparing the Foley Balloon Catheter with Oral Misoprostol

This one-page document summarizes research, carried out in two public hospitals in India, showing oral misoprostol to be more effective than a Foley balloon catheter in inducing labor in women with preeclampsia or high blood pressure. The results could prove useful as part of the development of clinical guidelines and recommendations in low-resource settings.

The article on which this summary is based is published in The Lancet (Mundle et al. 2017) and is available here.

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Improving Care at Delivery for Women with Preeclampsia: Comparing the Foley Balloon Catheter with Oral Misoprostol

This one-page document summarizes research, carried out in two public hospitals in India, showing oral misoprostol to be more effective than a Foley balloon catheter in inducing labor in women with preeclampsia or high blood pressure. The results could prove useful as part of the development of clinical guidelines and recommendations in low-resource settings.

The article on which this summary is based is published in The Lancet (Mundle et al. 2017) and is available here.

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Foley catheterisation versus oral misoprostol for induction of labour in hypertensive women in India (INFORM): a multicentre, open-label, randomised controlled trial

Background
Between 62 000 and 77 000 women die annually from pre-eclampsia and eclampsia. Prompt delivery, preferably by the vaginal route, is vital for good maternal and neonatal outcomes. Two low-cost interventions—low-dose oral misoprostol tablets and transcervical Foley catheterisation—are already used in low-resource settings. We aimed to compare the relative risks and benefits of these interventions.

Methods
We undertook this multicentre, open-label, randomised controlled trial in two public hospitals in Nagpur, India. Women (aged ≥18 years) who were at 20 weeks’ gestation or later with a live fetus and required delivery as a result of pre-eclampsia or hypertension were randomly assigned (1:1), via computer-generated block randomisation (block sizes of four, six, and eight) with concealment by use of opaque, sequentially numbered, sealed envelopes, to receive labour induction with either oral misoprostol 25 μg every 2 h (maximum of 12 doses) or a transcervical Foley catheter (silicone, size 18 F with 30 mL balloon). Randomisation was stratified by study centre. The catheter remained in place until active labour started, the catheter fell out, or 12 h had elapsed. If the catheter did not fall out within 12 h, induction continued with artificial membrane rupture and oxytocin, administered through a micro-drip gravity infusion set. Fetal monitoring was by intermittent auscultation. The primary outcome was vaginal birth within 24 h. Due to the nature of the interventions, masking of participants, study investigators, and care providers to group allocation was not possible. We analysed by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01801410.

Findings
Between Dec 20, 2013, and June 29, 2015, we randomly assigned 602 women to induction with misoprostol (n=302) or the Foley catheter (n=300; intention-to-treat population). Vaginal birth within 24 h was more common in women in the misoprostol group than in the Foley catheter group (172 [57·0%] vs 141 [47·0%] women; absolute risk difference 10·0%, 95% CI 2·0–17·9; p=0·0136). Rates of uterine hyperstimulation were low in both the misoprostol and Foley catheter groups (two [0·7%] vs one [0·3%] cases; absolute risk difference 0·3%, 95% CI −0·8 to 1·5; p=0·566) and neonatal deaths did not differ significantly between groups (six [2·0%] vs three [1·0%] neonatal deaths; 1·0, −1·04 to 2·97; p=0·322). 17 serious adverse events (3%) were reported during the study: one case of intrapartum convulsion and one case of disseminated intravascular coagulation (both in the Foley group); ten perinatal deaths, including two stillbirths (both in the Foley catheter group) and eight neonatal deaths (n=5 in the misoprostol group and n=3 in the Foley catheter group); and five of neonatal morbidity, comprising birth asphyxia (n=3), septicaemia (n=1), and neonatal convulsion (n=1).

Interpretation
Oral misoprostol was more effective than transcervical Foley catheterisation for induction of labour in women with pre-eclampsia or hypertension. Future studies are required to assess whether oxytocin augmentation following misoprostol can be replaced by regular doses of oral misoprostol tablets.

Funding
Medical Research Council, Department for International Development, and Wellcome Trust Joint Global Health Trials Scheme.

Access the full article at The Lancet (Mundle et al. 2017).

  • Topic: Preeclampsia
  • Type: Staff Publication
  • Author: Mundle, S., Bracken, H., Khedikar, V., Mulik, J., Faragher, B., Easterling, T., Leigh, S., Granby, P., Haycox, A., Turner, M.A., Alfirevic, Z., Winikoff, B., Weeks, A.D.
  • Published: June 2017

Postpartum Hemorrhage Prevention in Nepal: A Program Assessment

As part of broader efforts to improve the safety of childbirth, the Nepal Ministry of Health launched in 2009 a national postpartum hemorrhage (PPH) prevention program featuring the advance provision of misoprostol to pregnant women for use during home births. A Gynuity-sponsored assessment of the program was conducted four years later in nine districts and all three ecological regions — mountain, hill and terai (flatland terrain) — of Nepal. Interviews were conducted with women who had recently given birth to assess knowledge, receipt and use of misoprostol. Interviews were also conducted with Female Community Health Volunteers (FCHVs) and staff at health facilities to assess the supply and provision of misoprostol. The program assessment findings, along with recommendations for strengthening the program, are freely available to read in full.

Access the full article (available in Open Access) BMC Pregnancy and Childbirth 5 June 2017; Vol 17: 169.

Postpartum Hemorrhage Prevention in Nepal: A Program Assessment

This one-page document summarizes an assessment of Nepal’s national postpartum hemorrhage prevention program. The assessment focused in particular on the advance provision of misoprostol to pregnant women for use during home births and was carried out by Nepal’s Ministry of Health and Population, Gynuity Health Projects, and New ERA. The article on which this summary is based is published in the BMC Pregnancy and Childbirth (Rajbhandari et al. 2017) and is available to download here.

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FAQs on the Use of Multilevel Pregnancy Tests for Medical Abortion

Gynuity compiled a series of Frequently Asked Questions (FAQs) and their answers aimed at giving medical abortion providers and women information about how multilevel pregnancy tests can be used to rule out an ongoing pregnancy after medical abortion.

The "text only" version in this language is not currently available.

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FAQs on the Use of Multilevel Pregnancy Tests for Medical Abortion

Gynuity compiled a series of Frequently Asked Questions (FAQs) and their answers aimed at giving medical abortion providers and women information about how multilevel pregnancy tests can be used to rule out an ongoing pregnancy after medical abortion.

The "text only" version in this language is not currently available.

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FAQs on the Use of Multilevel Pregnancy Tests for Medical Abortion

Gynuity compiled a series of Frequently Asked Questions (FAQs) and their answers aimed at giving medical abortion providers and women information about how multilevel pregnancy tests can be used to rule out an ongoing pregnancy after medical abortion.

The "text only" version in this language is not currently available.

Download PDF in English

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FAQs on the Use of Multilevel Pregnancy Tests for Medical Abortion

Gynuity compiled a series of Frequently Asked Questions (FAQs) and their answers aimed at giving medical abortion providers and women information about how multilevel pregnancy tests can be used to rule out an ongoing pregnancy after medical abortion.

A "text only" version is available for users with slower internet connections.

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Sixteen Years of Overregulation: Time to Unburden Mifeprex

Researchers criticize the FDA regulation mechanism known as a “REMS” (Risk Evaluation and Mitigation Strategy). The REMS restrictions, implemented when mifepristone was first introduced in the U.S. in 2000, are inconsistent with how most drugs are regulated. Stringent REMS restrictions are only used for a small number of drugs, typically those with either a limited safety record or serious risk of complication or abuse. The REMS place medically unnecessary burdens on patients and providers, and keep mifepristone from being prescribed by clinicians or sold in pharmacies alongside hundreds of other prescription medications. Overregulation means that fewer providers offer mifepristone and fewer women have access to this safe and effective option for ending a pregnancy. Removal of the REMS would also foster opportunities for innovation in service delivery and important opportunities to increase access to safe abortion. Medical abortion has potential to fill in gaps in abortion access: it doesn’t require the infrastructure or facilities that other abortion procedures require and could be better integrated into the U.S. health system by expanding who provides it, how, and when. Removing the REMS would also help make medical abortion through telemedicine possible for some women in underserved areas.

New England Journal of Medicine. 2017 Feb;376(8):790-794.
  • Topic: Medical Abortion
  • Type: Staff Publication
  • Author: Raymond, E.G., Blanchard, K., Blumenthal, P.D., Cleland, K., Foster, A. M., Gold, M., Grossman, D., Pendergast, M.K., Westhoff, C.L., Winikoff, B.
  • Published: February 2017

Standardizing abortion research outcomes (STAR): A protocol for developing, dissemination and implementing a core outcome set for medical and surgical abortion.

Approximately one in four of all pregnancies will end in induced abortion with an estimated 56 million taking place worldwide every year [1]. Medical and surgical abortions have low complication rates; however, due to the ubiquity of abortion and the potential for complications if performed unsafely or inappropriately, the need for robust clinical trials and sound guidelines and recommendations is clear [1,2]. Besides the recent release of the Medical Abortion Reporting of Efficacy guidelines, there is a lack of standardized methods for selecting and reporting on outcomes in abortion clinical trials.

Contraception. 2017 Jan 5 [Epub ahead of print].

  • Topic: Medical Abortion
  • Type: Staff Publication
  • Author: Whitehouse, K.C., Kim, C.R., Ganatra, B., Duffy, J.M., Blum, J., Brahmi, D., Creinin, M.D., DePiñeres, T., Gemzell-Danielsson, K., Grossman, D., Winikoff, B., Gülmezoglu, A.M.
  • Published: January 2017

Serial Multilevel Urine Pregnancy Testing to Assess Medical Abortion Outcome: A Meta-analysis

Objectives
To summarize data on the accuracy of a strategy designed to exclude ongoing pregnancy after medical abortion treatment by observing a decline in urine human chorionic gonadotropin (hCG) concentration as estimated by multilevel urine pregnancy tests (MLPTs) performed before and after treatment.

Study Design
We collated original data from seven studies performed by our organization that evaluated the accuracy of the MLPT strategy for assessment of outcome of medical abortion. Our first analysis included data from the five studies in which each participant was evaluated both with the MLPT strategy and with ultrasound or other clinical assessment. Our second analysis combined data from two randomized trials that compared the MLPT strategy to assessment by ultrasound. Both analyses included only participants treated at≤63 days of gestation.

Results
In the first analysis, 1482 of 1599 participants (93%) had a decline in hCG concentration after treatment. Twenty-one (1.3%) had an ongoing pregnancy, none of whom had a decline (predictive value 100%, 95% CI 93.3%, 100%). The remaining 96 women (6.0%) had no decline without an ongoing pregnancy. The second analysis, which included 3762 participants with follow-up, found no significant difference in the rates of ongoing pregnancy ascertained in the randomized groups (RR 0.88; 95% CI 0.50, 1.54). Nearly all of the post-treatment MLPTs in the seven studies (3484/3535; 99%) were performed by the participants themselves.

Conclusions
Serial multilevel urine pregnancy testing is a highly reliable and efficient strategy for excluding ongoing pregnancy after medical abortion at≤63 days of gestation.

Implications Statement.
Serial urine testing using MLPTs can obviate the need for routine ultrasound or examination after medical abortion treatment and can allow most women to avoid an in-person follow-up visit to the abortion facility.

Contraception. 2016 Dec 29. [Epub ahead of print].

  • Topic: Medical Abortion
  • Type: Staff Publication
  • Author: Raymond, E.G., Shochet, T., Blum, J., Sheldon, W.R., Platais, I., Bracken, H., Dabash, R., Weaver, M.A., Ngoc, N.T., Blumenthal, P.D., Winikoff, B.
  • Published: December 2016

Sexual violence-related pregnancies in eastern Democratic Republic of Congo: a qualitative analysis of access to pregnancy termination services

Background
Sexual violence has been prevalent throughout the armed conflict in eastern Democratic Republic of Congo (DRC). Research on sexual violence-related pregnancies (SVRPs) and pregnancy termination in eastern DRC, a context with high prevalence of sexual violence, high maternal mortality, and restrictive abortion laws, is scant but crucial to improving the overall health of women in the DRC. Understanding women’s perceptions and experiences related to an SVRP, and in particular to pregnancy termination in this context, is critical for developing effective, targeted programming.

Methods
Respondent-driven sampling (RDS) was used to recruit two subgroups of women reporting SVRPs, 1) women raising a child from an SVRP (parenting group) and 2) women who had terminated an SVRP (termination group), in Bukavu, DRC in 2012. Semi-structured qualitative interviews on pregnancy history and outcomes were conducted with a systematically selected sub-group of women recruited through RDS methodology. Interview responses were translated, transcribed and uploaded to the qualitative data analysis software Dedoose. Thematic content analysis, complemented by the constant comparative technique from grounded theory, was subsequently used as the analytic approach for data analysis.

Results
Fifty-five qualitative interviews (38 parenting group and 17 termination group) were completed. The majority of women in the termination group reported using traditional herbs to terminate the SVRP, which they often obtained on their own or through family, friends and traditional healers; whereas women in the parenting group reported ongoing pregnancies after attempting pregnancy termination with herbal medications. Three women in the termination group reported accessing services in a health center. Almost half of the women in the parenting group cited fear of death from termination as a reason for continuing the pregnancy. Other women in the parenting group contemplated pregnancy termination, but did not know where to access services. Potential legal ramifications and religious beliefs also influenced access to services.

Conclusions
Women in this study had limited access to evidence-based safe abortion care and faced potential consequences from unsafe abortion, including increased morbidity and mortality. Increased access to reproductive health services, particularly safe, evidence-based abortion services, is paramount for women with SVRPs in eastern DRC and other conflict-affected regions.

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  • Topic: Abortion
  • Type: Staff Publication
  • Author: Burkhardt, G., Scott, J., Onyango, M.A., Rouhani, S., Haider, S., Greiner, A., Albutt, K., VanRooyen, M., Bartels, S.
  • Published: December 2016

Neither vaginal nor buccal administration of 800 μg misoprostol alters mucosal and systemic immune activation or the cervicovaginal microbiome: a pilot study

OBJECTIVES:
The aim of the study was to assess the extent to which misoprostol alters mucosal or systemic immune responses following either buccal or vaginal administration.

METHODS:
This was a prospective, crossover pilot study of 15 healthy, reproductive-age women. Women first received 800 μg misoprostol either via buccal or vaginal administration and were crossed over 1 month later to receive the drug via the other route. Cervicovaginal lavage samples, cervical Cytobrush samples, cervicovaginal swabs, urine and blood were obtained immediately prior to drug administration and the following day. Parameters assessed included urine and cervicovaginal misoprostol levels, whole blood cytokine responses (by ELISA) to immune stimulation with lipopolysaccharide, peripheral blood and cervical lymphocyte phenotyping by flow cytometry, cervicovaginal antimicrobial peptide measurement by ELISA and vaginal microbial ecology assessment by 16S rRNA sequencing.

RESULTS:
Neither buccal nor vaginal misoprostol significantly altered local or systemic immune and microbiological parameters.

CONCLUSION:
In this pilot study, we did not observe significant alteration of mucosal or systemic immunology or vaginal microbial ecology 1 day after drug administration following either the buccal or vaginal route.

European Journal of Contraception and Reproductive Health Care. 2016 Dec;21(6):436-442.

  • Topic: Medical Abortion
  • Type: Staff Publication
  • Author: Kalams, S.A., Rogers, L.M., Smith, R.M., Barnett, L., Crumbo, K., Sumner, S., Prashad, N, Rybczyk, K, Milne, G, Dowd, S.E., Chong, E., Winikoff, B., Aronoff, D.M.
  • Published: December 2016

Second trimester medical abortion with mifepristone followed by unlimited dosing of buccal misoprostol in Armenia

OBJECTIVES:
The aim of the study was to assess the efficacy and acceptability of a regimen using mifepristone and buccal misoprostol with unlimited dosing for second trimester abortion in Armenia.

METHODS:
Women seeking to terminate 13-22 week pregnancies were enrolled in the study. Participants swallowed 200 mg mifepristone in the clinic and were instructed to return to the hospital for induction 24-48 h later. During induction, women were given 400 μg buccal misoprostol every 3 h until the fetus and placenta were expelled. The abortion was considered a success if complete uterine evacuation was achieved without oxytocin or surgery.

RESULTS:
A total of 120 women with a median gestational age of 18 weeks participated in the study. All women began misoprostol induction around 24 h after taking mifepristone. Complete uterine evacuation was achieved in 119 (99.2%) women. The median induction-to-abortion interval was 10.3 h (range 4-17.4) with a mean of 9.5 ± 2.5 h. A median of four misoprostol doses (range 2-6) with a mean of 4 ± 1 misoprostol doses were administered. The induction-to-abortion interval, number of misoprostol doses, pain score and analgesia use increased as gestational age advanced. Acceptability of the method was high among both patients and providers.

CONCLUSION:
The medical abortion regimen of 200 mg mifepristone followed 24 h later by induction with 400 μg buccal misoprostol administered every 3 h, with no limit on the number of doses used for the termination of pregnancies of 13-22 weeks’ gestation is an effective and acceptable option for women.

European Journal of Contraception and Reproductive Health Care. 2017 Feb;22(1):76-80.

Simultaneous Administration Compared With a 24-Hour Mifepristone-Misoprostol Interval in Second-Trimester Abortion: A Randomized Controlled Trial

OBJECTIVE:
To compare outcomes with simultaneous administration of mifepristone and misoprostol with a regimen in which the drugs are administered at a 24-hour interval for second-trimester abortion.

METHODS:
In this placebo-controlled, double-blind trial, participants were randomized to receive mifepristone either 24 hours before or at the same time as misoprostol. Participants were hospitalized to receive 400 micrograms buccal misoprostol at 3-hour intervals up to 48 hours or until uterine expulsion. The primary outcome was the proportion of women who experienced uterine expulsion within 24 hours after the first misoprostol dose and this required 504 women to examine our hypothesis that this rate would be 85% in the 24-hour interval arm compared with 70% in the simultaneous arm. Secondary outcomes included total abortion time from mifepristone and misoprostol.

RESULTS:
From February 2013 to April 2014, 509 women were enrolled. Women in the 24-hour interval arm were more likely to abort within 24 hours (94.4% compared with 85.0%, relative risk 1.11, 95% confidence interval [CI] 1.05-1.18). At 48 hours, the rate was similar in the two arms (96.8% [24-hour interval] and 95.7% [simultaneous], relative risk 1.01, 95% CI 0.97-1.04). Median misoprostol dosing time was shorter in the 24-hour interval arm (7.7 compared with 13 hours; P<.001) and consistent with the median misoprostol doses required (three compared with five; P<.001). Median time from mifepristone to uterine expulsion was longer in the 24-hour interval arm (32.3 compared with 13 hours; P<.001). Both regimens had high acceptability rates and reported similar side effects and pain scores.

CONCLUSION:
Administering mifepristone and misoprostol simultaneously results in lower expulsion rates within 24 hours of taking misoprostol, longer median misoprostol treatment times, and requires more misoprostol doses. At 48 hours, both regimens work equally well. Simultaneous dosing results in less total time from the first clinical contact to complete abortion.

CLINICAL TRIAL REGISTRATION:
ClinicalTrials.gov, https://clinicaltrials.gov, NCT01768299.

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Two prophylactic medication approaches in addition to a pain control regimen for early medical abortion < 63 days' gestation with mifepristone and misoprostol: study protocol for a randomized, controlled trial.

BACKGROUND:
Pain is often cited as one of the worst features of medical abortion. Further, inadequate pain management may motivate some women to seek unnecessary clinical care. There is a need to identify effective methods for pain control in this setting.

METHODS/DESIGN:
We propose a randomized, placebo-controlled trial. 576 participants (288 nulliparous; 288 parous) from study sites in Nepal, South Africa and Vietnam will be randomly allocated to one of three treatments: (1) ibuprofen 400 mg PO and metoclopramide 10 mg PO; (2) tramadol 50 mg PO and a placebo; or (3) two placebo pills, to be taken immediately before misoprostol and repeated once four hours later. All women will be provided with supplementary analgesia for use as needed during the medical abortion. We hypothesize that women receiving prophylactic analgesia will report lower maximal pain scores in the first 8 h following misoprostol administration compared to women receiving placebos for medical abortion through 63 days’ gestation. Our primary objective is to determine whether prophylactic administration of ibuprofen and metoclopramide or tramadol provides superior pain relief compared to analgesia administration after pain begins, measured during the first eight hours after misoprostol administration. Secondary objectives include identifying covariates associated with higher reported pain scores; determining any impact of the study medicines on medical abortion success; and, qualitatively exploring women’s physical experiences of medical abortion, especially related to pain, and how can they be improved. Data sources include medical records, participant symptom diaries and interview data obtained on the day of enrollment, during the medical abortion, and at follow-up. Participants will be contacted via telephone on day 3 and return for follow-up will occur approximately 14 days after mifepristone, concluding study participation. A subset of 42 women will also be invited to undergo in-depth qualitative interviews following study completion.

DISCUSSION:
Although pain is one of the most common side effects encountered with medical abortion, little is known about optimal pain management for this process. This multi-arm trial design offers an efficient approach to evaluating two prophylactic pain management regimens compared to use of pain medication as needed.

TRIAL REGISTRATION:
ACTRN12613000017729 (Prospectively registered 8/1/2013).

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  • Topic: Medical Abortion
  • Type: Staff Publication
  • Author: Dragoman, M.V., Grossman, D., Kapp, N., Huong, N,M., Habib, N., Dung, D.L., Tamang, A.
  • Published: October 2016

Acceptability and feasibility of 400 μg buccal misoprostol after 200 mg mifepristone for early medical abortion in Georgia

OBJECTIVES:
The aim of the study was to examine the acceptability and feasibility of early medical abortion using 200 mg mifepristone and 400 μg buccal misoprostol in Georgia, outside the capital city of Tbilisi.

METHODS:
A total of 622 women in four regions of western and eastern Georgia who presented for termination of pregnancy at up to 63 d of gestation were enrolled in the study. In the western regions, women took one 200 mg pill of mifepristone in the clinic and were given the option of administering 400 μg misoprostol buccally, either at the clinic or at home, 24-48 h later. In the eastern region, women were given the option to take both drugs at home. Abortion status was determined 2 weeks after mifepristone administration.

RESULTS:
Ninety-five percent of participants had a successful abortion. Twenty-one percent of women in the eastern region elected to take mifepristone at home; nearly all participants in both regions (98%) chose to take misoprostol at home. Ninety-five percent of women were very satisfied or satisfied with the method, and 95% said they would prefer medical abortion for a future procedure.

CONCLUSIONS:
Medical abortion with mifepristone and 400 μg buccal misoprostol is an acceptable and feasible option for women in Georgia, outside the capital city of Tbilisi.

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Effects of Depot Medroxyprogesterone Acetate Injection Timing on Medical Abortion Efficacy and Repeat Pregnancy: A Randomized Controlled Trial

OBJECTIVE:
To evaluate the effects of timing of depot medroxyprogesterone acetate injection on medical abortion outcome and risk of repeat pregnancy within the subsequent 6 months.

METHODS:
In a multinational randomized trial, we assigned women undergoing medical abortion who wanted depot medroxyprogesterone acetate to administration either with mifepristone (Quickstart group) or after the abortion (Afterstart group). We ascertained abortion outcome, pregnancies, and contraception use over 7 months.

RESULTS:
From August 2013 to March 2015, we enrolled 461 participants with pregnancy durations of 75 days or less. Of participants included in the abortion outcome analyses, 14 of 220 (6.4%) and 12 of 226 (5.3%) in the Quickstart and Afterstart groups, respectively, had surgery to complete the abortion; the upper 90% confidence limit on this difference was 4.9%, within our prestipulated 5% noninferiority margin. Ongoing pregnancy after initial abortion treatment was significantly more common in the Quickstart group (8/220 [3.6%]) than in the Afterstart group (2/226 [0.9%]); the difference was 2.7% (90% confidence interval 0.4-5.6%). By 6 months, 5 of 213 (2.3%) and 7 of 217 (3.2%) in the Quickstart and Afterstart groups, respectively, became pregnant (exact log-rank test, P=.64). Use of highly effective contraceptives was significantly more common in the Quickstart group at 31 days (P<.001), but no difference was apparent at 6 months. The Quickstart group was significantly more satisfied with group assignment.

CONCLUSION:
Depot medroxyprogesterone acetate administration with mifepristone did not appreciably increase the risk of surgery after medical abortion but did increase the risk of ongoing pregnancy. It enhanced patient satisfaction, but we found no evidence that it decreased 6-month risk of repeat pregnancy.

CLINICAL TRIAL REGISTRATION:
ClinicalTrials.gov, https://clinicaltrials.gov, NCT01902485.

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  • Topic: Medical Abortion
  • Type: Staff Publication
  • Author: Raymond, E.G., Weaver, M.A., Louie, K.S., Tan, Y.L., Bousiéguez, M., Aranguré-Peraza, A.G., Lugo-Hernández E. M., Sanhueza, P., Goldberg, A.B., Culwell, K.R., Kaplan, C., Memmel, L., Sonalkar, S., Jamshidi, R., Winikoff, B.
  • Published: October 2016

Prospective study of home use of mifepristone and misoprostol for medical abortion up to 10weeks of pregnancy in Kazakhstan

OBJECTIVE:
To evaluate the efficacy of at-home medical abortion in Kazakhstan.

METHODS:
A comparative, non-randomized study was undertaken at three clinics in Kazakhstan between October 10, 2013, and November 27, 2014. Women who sought medical abortion and had an intrauterine pregnancy of up to 70days were enrolled. All participants took 200mg mifepristone followed by 600μg sublingual misoprostol 24-48hours later. Women were offered the choice to take mifepristone at the clinic or at home; all took misoprostol at home. Abortion completion was assessed at an in-clinic follow-up appointment scheduled for all participants 2weeks after mifepristone administration.

RESULTS:
Of 290 enrolled women, 185 (63.8%) chose to self-administer mifepristone at home. Three (1.0%) of 289 women included in outcome analyses required surgical intervention for incomplete abortion. Therefore, the overall success rate was 99.0% (95% confidence interval 97.0%-99.7%). No serious adverse events occurred.

CONCLUSION:
Outpatient medical abortion with mifepristone and misoprostol is safe and effective up to 70days of pregnancy. This service should be offered to women in Kazakhstan. ClinicalTrials.gov: NCT02018796.

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Prospective study of home use of mifepristone and misoprostol for medical abortion up to 10weeks of pregnancy in Kazakhstan

OBJECTIVE:
To evaluate the efficacy of at-home medical abortion in Kazakhstan.

METHODS:
A comparative, non-randomized study was undertaken at three clinics in Kazakhstan between October 10, 2013, and November 27, 2014. Women who sought medical abortion and had an intrauterine pregnancy of up to 70days were enrolled. All participants took 200mg mifepristone followed by 600μg sublingual misoprostol 24-48hours later. Women were offered the choice to take mifepristone at the clinic or at home; all took misoprostol at home. Abortion completion was assessed at an in-clinic follow-up appointment scheduled for all participants 2weeks after mifepristone administration.

RESULTS:
Of 290 enrolled women, 185 (63.8%) chose to self-administer mifepristone at home. Three (1.0%) of 289 women included in outcome analyses required surgical intervention for incomplete abortion. Therefore, the overall success rate was 99.0% (95% confidence interval 97.0%-99.7%). No serious adverse events occurred.

CONCLUSION:
Outpatient medical abortion with mifepristone and misoprostol is safe and effective up to 70days of pregnancy. This service should be offered to women in Kazakhstan. ClinicalTrials.gov: NCT02018796.

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A crossover pharmacokinetic study of misoprostol by the oral, sublingual and buccal routes

OBJECTIVES: The aim of the study was to compare the pharmacokinetic parameters of 800 μg oral, sublingual and buccal misoprostol in healthy non-pregnant women.

METHODS: This was an open-label, randomised study with a three-way crossover design. Eighteen participants were randomly assigned to treatment sequences of 800 μg oral, sublingual and buccal misoprostol administered under fasting conditions, with a 7-day washout period. Ten participants completed all routes. The primary pharmacokinetic parameters measured were the area under the plasma misoprostol acid concentration-time curve (AUC) from dosing to last quantifiable concentration (AUC0-t), the AUC from 0 to infinity (AUC0-∞) and the maximum plasma concentration (Cmax). Secondary parameters included the plasma elimination rate constant (ke), the half-life and the mean residence time (MRT).

RESULTS: There were statistically significant differences in AUC0-∞, AUC0-t and Cmax at the p < 0.05 level for the three routes of administration. The sublingual route achieved the highest bioavailability, and the buccal route achieved the lowest peak concentration. The oral and buccal routes had a similar AUC0-∞ and the buccal route had the highest MRT and ke. There were no differences in half-lives, and no serious adverse events were reported.

CONCLUSIONS: This study shows variability in Cmax and AUC by three by-mouth routes of misoprostol administration. The dose in this study was 800 μg, which is among the highest doses seen in current guidelines. These data contribute to the understanding of efficacy and safety of different routes and could provide a basis for deciding whether certain routes are preferable for particular indications.

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Randomized trial assessing home use of two pregnancy tests for determining early medical abortion outcomes at 3, 7 and 14 days after mifepristone

Objective
To evaluate the accuracy, feasibility and acceptability of two urine pregnancy tests in assessing abortion outcomes at three time points after mifepristone administration.

Study design
This randomized trial enrolled women seeking early medical abortion at two hospitals in Vietnam. Investigators randomly allocated participants to at-home administration of a multilevel urine pregnancy test (MLPT) or a high sensitivity urine pregnancy test (HSPT) to assess their abortion outcomes. A baseline test was administered on the same day as mifepristone. Participants performed and interpreted results of pregnancy tests taken 3, 7 and 14 days after mifepristone. Ultrasound exam determined continuing pregnancy.

Results
Six hundred women enrolled, and 300 received each test. A percentage of 97.4 (584) had follow-up, of whom 13 women had continuing pregnancies. The specificity of MLPT at detecting absence of continuing pregnancy was 63.9%, 90.4% and 97.1% at study day 3, 7 and 14. The specificity of HSPT was 6.0%, 19.8% and 62.2%, respectively. The positive predictive value (PPV) of MLPT at detecting continuing pregnancy was 6.4% at day 3 and rose to 46.7% at day 14. In contrast, the PPV for HSPT was 2.2% at day 3 and rose to 6.5% at day 14. At all three time points, the sensitivity and negative predictive values for both tests were 100.0%. Most women found their assigned tests easy to use and would prefer future home follow-up with a pregnancy test.

Conclusions
The MLPT enables women to assess their abortion outcomes more reliably than with HSPT. With MLPT, women can know their outcomes as early as 3 days after mifepristone.

Implications
Medical abortion service delivery with an MLPT to obtain a baseline (preabortion) human chorionic gonadotropin (hCG) estimate and a second follow-up MLPT 1 to 2 weeks later can establish whether there has been a drop in hCG, signifying absence of a continuing pregnancy. Used this way, MLPTs can enable women to assess their abortion status outside of a clinic setting and without serum hCG testing and/or ultrasound.

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  • Topic: Medical Abortion
  • Type: Staff Publication
  • Author: Blum, J., Sheldon, W.R., Ngoc, N.T., Winikoff, B., Nga, N.T., Martin, R., Van Thanh, L., Blumenthal, P.D.
  • Published: August 2016

Self-administered multi-level pregnancy tests in simplified follow-up of medical abortion in Tunisia

BACKGROUND:
This study was conducted to assess the efficacy and acceptability of using a multi-level pregnancy test (MLPT) combined with telephone follow-up for medical abortion in Tunisia, where the majority of providers are midwives.

METHODS:
Four hundred and four women with gestational age ≤ 70 days’ LMP seeking medical abortion at six study sites were enrolled in this open-label trial. Participants administered a baseline MLPT at the clinic prior to mifepristone administration and were asked to take a second MLPT at home and to call in its results before returning the day of their scheduled follow-up visit 10-14 days later.

RESULTS:
Almost all women with follow-up (97.1 %, n = 332/342) had successful abortions without the need for surgical intervention. The MLPT worked extremely well among women ≤63 days’ LMP in ruling out ongoing pregnancy (negative predictive value (NPV) =100 % (n = 298/298)) and also detecting women with ongoing pregnancies (sensitivity = 100 %; 2/2) as needing follow-up due to non-declining hCG. Among women 64-70 days’ LMP, the test also worked well in ruling out ongoing pregnancy (NPV = 96.9 % (n = 31/32) but not as well in terms of sensitivity (50 %), with only one of two ongoing pregnancies detected by MLPT as needing follow-up. Most women (95.1 %) found the MLPT to be very easy or easy to use and would consider using the MLPT again (97.4 %) if needed.

CONCLUSIONS:
Self-administered pre and post MLPT are very easy for women to use and accurate in assessing medical abortion success up to 63 days’ LMP. MLPT use for medical abortion follow-up has the potential to facilitate task sharing services and eliminate the burden of routine in-person follow-up visits for the large majority of women. Additional research is warranted to explore the accuracy of the MLPT in identifying ongoing pregnancy among women with gestational ages > 63 days.

TRIAL REGISTRATION:
This study was registered on May 13, 2010, on clinicaltrials.gov as NCT01150279 .

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  • Topic: Medical Abortion
  • Type: Staff Publication
  • Author: Dabash, R., Shochet, T., Hajri, S., Chelli, H., Hassairi, A.E., Haleb, D., Labassi, H., Sfar, E., Temimi, F., Koenig, L., Winikoff, B.
  • Published: July 2016

Postpartum Hemorrhage Program Brief

This Program Brief outlines Gynuity’s body of work in the area of postpartum hemorrhage management. The brief is accompanied by an insert listing articles on PPH that have been published in peer-reviewed journals.

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Preventing postpartum hemorrhage at the community level

This one-page document summarizes community-level research showing that misoprostol distributed antenatally for self-administration can be appropriately taken by women delivering at home. The pilot study was conducted in rural Uganda by the University of Liverpool, Gynuity Health Projects, and Makerere University.

The article on which this summary is based is published in BMC Pregnancy and Childbirth and is available here.

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  • Topic: Postpartum hemorrhage
  • Type: Staff Publication
  • Author: Weeks, A.D., Ditai, J., Ononge, S., Faragher, B., Frye, L.J., Durocher, J., Mirembe, F.M., Byamugisha, J., Winikoff, B., Alfirevic, Z.
  • Published: September 2015

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Increasing Access to Abortion With Telemedicine

For many women in the United States, obtaining an abortion is unduly difficult. In 2008, a national survey found that 31% of patients in rural areas traveled more than 100 miles for abortion services. Subsequently, states have enacted hundreds of new restrictions on abortion, including limits on the construction of facilities, the qualifications for clinicians, and the procedures that are used for abortion. At present, Mississippi, Missouri, South Dakota, and North Dakota each have only 1 operational outpatient abortion clinic, and Wyoming has none. Once a woman reaches an abortion facility, she may encounter additional barriers, including verbal harassment by protestors and physical blocking of the clinic entry. This harassment is sometimes violent: in November 2015, 3 people were killed at a Planned Parenthood clinic in Colorado Springs, Colorado. The health consequences of impeding access to abortion may be serious: women may delay the procedure, which increases risk, or resort to unsafe abortion methods. Ultimately, some women may be unable to obtain an abortion at all, resulting in unwanted births.

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Innovative research at the 2016 National Abortion Federation Annual Meeting: continuously improving abortion care

In April of this year, the National Abortion Federation (NAF) held our 40th Annual Meeting, which brought together researchers, clinicians, administrators, counselors, advocates and students to share the latest research in abortion care. As the professional association of abortion providers, NAF is committed to disseminating research results to improve abortion care for women globally. NAF’s Annual Meeting is a remarkable opportunity for researchers to present their findings directly to the clinicians and others who will implement those results.

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  • Topic: Medical Abortion
  • Type: Staff Publication
  • Author: Reeves, M.F., Blumenthal, P.D., Jones, R.K., Nichols, M.D., Shumaker, H., Saporta, V.A.
  • Published: May 2016

Medical abortion

Abstract

OBJECTIVE: This guideline reviews the evidence relating to the provision of first-trimester medical induced abortion, including patient eligibility, counselling, and consent; evidence-based regimens; and special considerations for clinicians providing medical abortion care.

INTENDED USERS: Gynaecologists, family physicians, registered nurses, midwives, residents, and other healthcare providers who currently or intend to provide pregnancy options counselling, medical abortion care, or family planning services.

TARGET POPULATION: Women with an unintended first trimester pregnancy.

EVIDENCE: Published literature was retrieved through searches of PubMed, MEDLINE, and Cochrane Library between July 2015 and November 2015 using appropriately controlled vocabulary (MeSH search terms: Induced Abortion, Medical Abortion, Mifepristone, Misoprostol, Methotrexate). Results were restricted to systematic reviews, randomized controlled trials, clinical trials, and observational studies published from June 1986 to November 2015 in English. Additionally, existing guidelines from other countries were consulted for review. A grey literature search was not required.

VALUES: The quality of evidence in this document was rated using the criteria described in the Report of the Canadian Task Force for Preventive Medicine rating scale (Table 1).

BENEFITS, HARMS AND/OR COSTS: Medical abortion is safe and effective. Complications from medical abortion are rare. Access and costs will be dependent on provincial and territorial funding for combination mifepristone/misoprostol and provider availability.

SUMMARY STATEMENTS: Introduction Pre-procedure care Medical abortion regimens Providing medical abortion Post-abortion care

RECOMMENDATIONS: Introduction Pre-procedure care Medical abortion regimens Providing medical abortion Post-abortion care.

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  • Topic: Medical Abortion
  • Type: Staff Publication
  • Author: Costescu, D., Guilbert, E., Bernardin, J., Black, A., Dunn, S., Fitzsimmons, B., Norman, W.V., Pymar, H., Soon, J., Trouton, K., Wagner, M.S., Wiebe, E., Gold, K., Murray, M.È., Winikoff, B., Reeves, M.
  • Published: April 2016

Postpartum Hemorrhage Program Brief

This Program Brief outlines Gynuity’s body of work in the area of postpartum hemorrhage management. The brief is accompanied by an insert listing articles on PPH that have been published in peer-reviewed journals.

A "text only" version is available for users with slower internet connections.

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Postpartum Hemorrhage Program Brief

This Program Brief outlines Gynuity’s body of work in the area of postpartum hemorrhage management. The brief is accompanied by an insert listing articles on PPH that have been published in peer-reviewed journals.

The "text only" version in this language is not currently available.

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Oxytocin in Uniject™ versus misoprostol for prevention of postpartum hemorrhage at the community level: A cluster randomized controlled trial

Where access to conventional injectable uterotonics to prevent PPH is limited, alternative intervention options using uterotonics could play an important role in reducing the incidence of PPH when given to women after childbirth by less skilled providers. This one-page document summarizes a study comparing the programmatic effectiveness and feasibility of misoprostol and oxytocin in Uniject™ for preventing PPH. While both drugs were found to be safe and efficacious, ease of use, higher acceptability and fewer logistical challenges made misoprostol a more adaptable intervention option in rural Senegal, the setting for the study.

The article on which this summary is based is published in Global Health Lancet (Diop et al. 2016) and is available here.

The "text only" version in this language is not currently available.

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Oxytocin in Uniject™ versus misoprostol for prevention of postpartum hemorrhage at the community level: A cluster randomized controlled trial

Where access to conventional injectable uterotonics to prevent PPH is limited, alternative intervention options using uterotonics could play an important role in reducing the incidence of PPH when given to women after childbirth by less skilled providers. This one-page document summarizes a study comparing the programmatic effectiveness and feasibility of misoprostol and oxytocin in Uniject™ for preventing PPH. While both drugs were found to be safe and efficacious, ease of use, higher acceptability and fewer logistical challenges made misoprostol a more adaptable intervention option in rural Senegal, the setting for the study.

The article on which this summary is based is published in Global Health Lancet (Diop et al. 2016) and is available here.

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Vaginal and Rectal Clostridium sordellii and Clostridium perfringens Presence Among Women in the United States

This observational cohort study evaluated the presence of Clostridium sordellii and Clostridium perfingens of a diverse group of reproductive-aged women in the United States. The results of this study suggest that the chances are exceedingly small that a woman would have C sordelli present in the vagina, that the lethal toxin gene would be present in that particular strain, and that the bacteria would remain long enough for it to produce toxins. At baseline, recent gynecologic surgery was associated with C sordellii presence, whereas a high body mass index was associated with C perfringens presence. Based on the data, use of routine antibiotics at the time of medical abortion would likely not be effective at reducing the presence of clostridia or reducing clostridial infection.

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  • Topic: Abortion
  • Type: Staff Publication
  • Author: Chong, E., Winikoff, B., Charles, D., Agnew, K., Prentice, J.L., Limbago, B.M., Platais, I., Louie, K., Jones, H.E., Shannon, C.
  • Published: February 2016

Effect of Immediate Compared with Delayed Insertion of Etonogestrel Implants on Medical Abortion Efficacy and Repeat Pregnancy: A Randomized Controlled Trial

The objective of this study was to evaluate the effects of an etonogestrel implant inserted the same day mifepristone is taken (Quickstart), as compared to the when given after the woman has taken mifepristone (Afterstart); participants were assigned to one of these two groups. Women were followed for 7 months to ascertain abortion outcome, pregnancies, and contraception use. Insertion of etonogestrel implants with mifepristone did not increase the risk of the medical abortion failure, and was shown to enhance patient satisfaction. However, this study found no evidence that it decreased repeat pregnancy rates.

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  • Topic: Medical Abortion
  • Type: Staff Publication
  • Author: Raymond, E.G., Weaver, M.A., Tan, Y.L., Louie, K.S., Bousiéguez, M., Lugo-Hernández, E.M., Aranguré-Peraza, A.G., Sanhueza, P., Kaplan, C., Sonalkar, S., Goldberg, A.B., Culwell, K.R., Memmel, L., Jamshidi, R., Winikoff, B.
  • Published: February 2016

A systematic review of the relationship between blood loss and clinical signs.

This review examined 30 studies involving women with haemorrhage, 5 of which focused on pregnancy-related haemorrhage, to see if there was a relationship between blood loss and clinical signs that could be used as triggers for clinical interventions. The authors found that there was considerable variability in this relationship. While there was a significant relationship between shock index and blood loss, it is difficult to establish specific cut-off points for other factors to indicate clinical intervention. Further research on the role of the shock index in obstetrics is needed.

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Misoprostol for primary versus secondary prevention of postpartum haemorrhage: a cluster-randomised non-inferiority community trial

The article describes a community trial implemented by a team from India and the USA that compared two approaches to the management of postpartum hemorrhage – the leading complication of childbirth that causes approximately a quarter of all maternal deaths each year. The study compared the current standard, ‘universal prophylaxis’ —a commonly-advocated community approach for reducing postpartum hemorrhage whereby every woman is administered a preventive uterotonic medicine to contract the uterus— to a novel approach, ‘secondary prevention/early treatment’ — where only the small proportion of women who bleed more than average are offered a treatment dose of misoprostol. Results show that the secondary prevention approach medicated substantially fewer women (4.7% versus 99.7%), who experienced significantly fewer side effects. There were no statistical differences in post-delivery hemoglobin levels, rate of postpartum hemorrhage, and rate of transfer to higher level facilities. The authors conclude that this new research shows secondary prevention/early treatment to be a feasible non-inferior alternative strategy to universally medicating all women who deliver with prophylaxis. The approach has the potential for being more acceptable, cost-effective and sustainable, with the additional potential to equip community-level providers with a timely strategy to manage bleeding before it reaches the point of an emergency.

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  • Topic: Postpartum hemorrhage, misoprostol
  • Type: Staff Publication
  • Author: Raghavan, S., Geller, S., Miller, S., Goudar, S.S., Anger, H., Yadavannavar, M.C., Dabash, R., Bidri, S.R., Gudadinni, M.R., Udgiri, R., Koch, A.R., Bellad, M.B., Winikoff, B.
  • Published: January 2016

Oxytocin via Uniject (a prefilled single-use injection) versus oral misoprostol for prevention of postpartum haemorrhage at the community level: a cluster-randomised controlled trial.

BACKGROUND:
Access to injectable uterotonics for management of postpartum haemorrhage remains limited in Senegal outside health facilities, and misoprostol and oxytocin delivered via Uniject have been deemed viable alternatives in community settings. We aimed to compare the efficacy of these drugs when delivered by auxiliary midwives at maternity huts.

METHODS:
We did an unmasked cluster-randomised controlled trial at maternity huts in three districts in Senegal. Maternity huts with auxiliary midwives located 3-21 km from the closest referral centre were randomly assigned (1:1; via a computer-generated random allocation overseen by Gynuity Health Projects) to either 600 μg oral misoprostol or 10 IU oxytocin in Uniject (intramuscular), stratified by reported previous year clinic volume (deliveries) and geographical location (inland or coastal). Maternity huts that had been included in a previous study of misoprostol for prevention of postpartum haemorrhage were excluded to prevent contamination. Pregnant women in their third trimester were screened for eligibility either during community outreach or at home-based prenatal visits. Only women delivered by the auxiliary midwives in the maternity huts were eligible for the study. Women with known allergies to prostaglandins or pregnancy complications were excluded. The primary outcome was mean change in haemoglobin concentration measured during the third trimester and after delivery. This study was registered with ClinicalTrials.gov, number NCT01713153.

FINDINGS:

28 maternity hut clusters were randomly assigned-14 to the misoprostol group and 14 to the oxytocin group. Between June 6, 2012, and Sept 21, 2013, 1820 women were recruited. 647 women in the misoprostol group and 402 in the oxytocin group received study drug and had recorded pre-delivery and post-delivery haemoglobin concentrations, and overall 1412 women delivered in the study maternity huts. The mean change in haemoglobin concentrations was 3·5 g/L (SD 16·1) in the misoprostol group and 2·7 g/L (SD 17·8) in the oxytocin group. When adjusted for cluster design, the mean difference in haemoglobin decreases between groups was not significant (0·3 g/L, 95% CI -8·26 to 8·92, p=0·71). Both drugs were well tolerated. Shivering was common in the misoprostol group, and nausea in the oxytocin group. Postpartum haemorrhage was diagnosed in one woman allocated to oxytocin, who was referred and transferred to a higher-level facility for additional care, and fully recovered. No other women were transferred.

INTERPRETATION:
In terms of effects on haemoglobin concentrations, neither oxytocin nor misoprostol was significantly better than the other, and both drugs were safe and efficacious when delivered by auxiliary midwives. The programmatic limitations of oxytocin, including short shelf life outside the cold chain, mean that misoprostol could be more appropriate for community-level prophylaxis of postpartum haemorrhage.

FUNDING:
Bill & Melinda Gates Foundation.

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Oxytocin in Uniject™ versus misoprostol for prevention of postpartum hemorrhage at the community level: A cluster randomized controlled trial

Where access to conventional injectable uterotonics to prevent PPH is limited, alternative intervention options using uterotonics could play an important role in reducing the incidence of PPH when given to women after childbirth by less skilled providers. This one-page document summarizes a study comparing the programmatic effectiveness and feasibility of misoprostol and oxytocin in Uniject™ for preventing PPH. While both drugs were found to be safe and efficacious, ease of use, higher acceptability and fewer logistical challenges made misoprostol a more adaptable intervention option in rural Senegal, the setting for the study.

The article on which this summary is based is published in Global Health Lancet (Diop et al. 2016) and is available here.

A "text only" version is available for users with slower internet connections.

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Contraception Program Brief

This summary describes Gynuity’s body of work in the area of Contraception.

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Contraception Program Brief

This summary describes Gynuity’s body of work in the area of Contraception.

A "text only" version is available for users with slower internet connections (Only available in English at this time)

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(Only English available at this time)

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Mifepristone label laws and trends in use: recent experiences in four US states

Since mifepristone was approved in 2000, the rate of medical abortions has risen fairly steadily from just 6% of all eligible abortions in 2001 to 29% in 2011. If unconstrained access to medical abortions were the norm, rather than the exception, medical abortions might constitute a higher percentage of all abortions. Furthermore, the on-label use of mifepristone involves use of an outdated regimen of 600 mg that is more expensive and arguably less effective, with greater side effects than the evidence-based regimen of 200 mg that is currently the world-wide standard of care. In order to examine further the possible effect of mifepristone-specific restrictions, researchers documented trends in mifepristone use over a 10-year period (2004–2014) in four large US states: California, New York, Ohio and Texas.

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Misoprostol for Primary Versus Secondary Prevention of postpartum Haemorrhage: A Cluster-Randomised Non-Inferiority Community Trial

This article describes a cluster-randomized community trial showing ‘secondary prevention’ —a novel approach to PPH management whereby only women who bleed more than average after delivery are given a preemptive treatment dose of misoprostol— to be non-inferior to ‘universal prophylaxis’. The study concludes that this early treatment approach could be a good alternative to universal prophylaxis as it medicates fewer women and is an acceptable and feasible strategy at the community level.

A One-page Summary of the research is available here

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Secondary Prevention/Early Treatment of Postpartum Hemorrhage: An Innovative New Model for PPH Management

This one-page document summarizes community-level research showing ‘secondary prevention’ —a novel approach to PPH management whereby only women who bleed more than average after childbirth are given a preemptive treatment dose of misoprostol— to be a feasible non-inferior alternative strategy to universally medicating all women who deliver with prophylaxis.

The article on which this summary is based is published in the British Journal of Obstetrics and Gynaecology (Raghavan et al. 2015) and is available here

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The MamaMiso study of self-administered misoprostol to prevent bleeding after childbirth in rural Uganda: a community-based, placebo-controlled randomised trial

Background
600 mcg of oral misoprostol reduces the incidence of postpartum haemorrhage (PPH), but in previous research this medication has been administered by health workers. It is unclear whether it is also safe and effective when self-administered by women.

Methods
This placebo-controlled, double-blind randomised trial enrolled consenting women of at least 34 weeks gestation, recruited over a 2-month period in Mbale District, Eastern Uganda. Participants had their haemoglobin measured antenatally and were given either 600mcg misoprostol or placebo to take home and use immediately after birth in the event of delivery at home. The primary clinical outcome was the incidence of fall in haemoglobin of over 20 % in home births followed-up within 5 days.

Results
748 women were randomised to either misoprostol (374) or placebo (374). Of those enrolled, 57 % delivered at a health facility and 43 % delivered at home. 82 % of all medicine packs were retrieved at postnatal follow-up and 97 % of women delivering at home reported self-administration of the medicine. Two women in the misoprostol group took the study medication antenatally without adverse effects. There was no significant difference between the study groups in the drop of maternal haemoglobin by >20 % (misoprostol 9.4 % vs placebo 7.5 %, risk ratio 1.11, 95 % confidence interval 0.717 to 1.719). There was significantly more fever and shivering in the misoprostol group, but women found the medication highly acceptable.

Conclusions
This study has shown that antenatally distributed, self-administered misoprostol can be appropriately taken by study participants. The rarity of the primary outcome means that a very large sample size would be required to demonstrate clinical effectiveness.

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  • Topic: Postpartum hemorrhage
  • Type: Staff Publication
  • Author: Weeks, A.D., Ditai, J., Ononge, S., Faragher, B., Frye, L.J., Durocher, J., Mirembe, F.M., Byamugisha, J., Winikoff, B., Alfirevic, Z.
  • Published: September 2015

If we can do it for misoprostol, why not for mifepristone? The case for taking mifepristone out of the office in medical abortion

Given the highly political nature of abortion in the United States, the provision of medical abortion with mifepristone and misoprostol has always occurred under a unique set of circumstances and restrictions. The current FDA-approved medical abortion regimen requires clinicians to administer mifepristone in the office, and requires women to return to the office for the misoprostol. Six studies, enrolling over 1800 women, found that the option of taking mifepristone out of the office was popular and acceptable among women and providers.

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Continuing pregnancy after mifepristone and "reversal" of first-trimester medical abortion: A systematic review

In early 2015, legislatures in Arizona and Arkansas passed laws requiring physicians providing abortion to inform women that if they choose to have a medical abortion, and decide not to complete the abortion, the effect of mifepristone may be reversed with specific treatment. This systemic literature review looks at the effectiveness of medical abortion “reversal” treatment. Only 1 study met the inclusion criteria for abortion reversal, and 13 studies met criteria for continuing pregnancy after mifepristone alone. The study that looked at reversing the effects of mifepristone was of poor quality and with few details: the mifepristone dosage was not noted, and only six patients had follow-up data. From the dearth of literature surrounding this topic, it is clear that there is insufficient evidence in the literature to determine whether treatment with progesterone after mifepristone results in a higher proportion of continuing pregnancies as compared to expectant management.

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  • Topic: Medical Abortion
  • Type: Staff Publication
  • Author: Grossman, D., White, K., Harris, L., Reeves, M., Blumenthal, P.D., Winikoff, B., Grimes, D.A.
  • Published: September 2015

Preventing postpartum hemorrhage at the community level

This one-page document summarizes community-level research showing that misoprostol distributed antenatally for self-administration can be appropriately taken by women delivering at home. The pilot study was conducted in rural Uganda by the University of Liverpool, Gynuity Health Projects, and Makerere University.

The article on which this summary is based is published in BMC Pregnancy and Childbirth and is available here.

A "text only" version is available for users with slower internet connections (Only available in English at this time)

Open Text Version in New Window

  • Topic: Postpartum hemorrhage
  • Type: Staff Publication
  • Author: Weeks, A.D., Ditai, J., Ononge, S., Faragher, B., Frye, L.J., Durocher, J., Mirembe, F.M., Byamugisha, J., Winikoff, B., Alfirevic, Z.
  • Published: September 2015

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Cervical Preparation Before Dilation and Evacuation Using Adjunctive Misoprostol or Mifepristone Compared With Overnight Osmotic Dilators Alone: A Randomized Controlled Trial.

This double-blind, three-arm, multicenter, randomized trial compared overnight osmotic dilators alone, dilators plus 400 micrograms buccal misoprostol 3 hours preoperatively, and dilators plus 200 mg oral mifepristone during dilator placement for dilation and evacuation for second trimester abortion. Despite no difference in operative time, adjunctive mifepristone facilitates later dilation and evacuation compared with osmoticdilators alone and is better tolerated than misoprostol.

Obstet Gynecol. 2015 Sep;126(3):599-609. doi: 10.1097/AOG.0000000000000977.

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  • Topic: Medical Abortion
  • Type: Staff Publication
  • Author: Goldberg, A.B., Fortin, J.A., Drey, E.A., Dean, G., Lichtenberg, E.S., Bednarek, P.H., Chen, B.A., Dutton, C., McKetta, S., Maurer, R., Winikoff, B., Fitzmaurice, G.M.
  • Published: September 2015

Home use of urine pregnancy tests for medical abortion follow-up

This article looks at two unique studies in order to address the question of whether a standard clinic follow-up is truly necessary after medical abortion. The primary reason for a return visit after a medical abortion is to determine whether there is an ongoing pregnancy. However, both studies suggest that home assessment using a multi-level urine pregnancy test?? after a medical abortion is safe, and that, in most cases, a clinic visit is not actually necessary.

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A prospective, non-randomized study of home-use of mifepristone for medical abortion in the U.S.

This prospective, non-randomized, open-label study at six Planned Parenthood centers gave women with pregnancies up to 63 days gestation seeking medical abortion the choice of taking mifepristone in the center or at home. Four hundred women were enrolled in the study, and 32% of those women chose to take mifepristone at home. Ninety-nine percent of home users reported that they would take mifepristone at home again and 96% would recommend home use to a friend. Home use of mifepristone did not increase the burden on service delivery providers.

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Comment on “Is It Safe to Provide Abortion Pills Over The Counter? A Study on Outcome Following Self-Medication with Abortion Pills”

Dear Editor,

We read with interest the article “Is it safe to Provide Abortion Pills over the Counter? A Study on Outcome Following Self-Medication with Abortion Pills” by Dr. K. Nivedita and Dr. Fatima Shanthini [1] and we agree that studying the implications of self-administration of abortion pills is a worthy research aim. However, the evidence presented does not support the authors’ conclusion that “unsupervised medical abortion can lead to increased maternal morbidity and mortality”.

The authors analysed the case sheets of 40 hospitalized women who reported self-administration of abortion pills, but this analysis lacks a meaningful denominator. Safety and efficacy cannot be known without quantifying the number of women in the catchment area who self-administered abortion pills and had complete and uncomplicated procedures and never sought follow up care. In fact, the data presented could indicate a very low failure and complication rate, depending on the denominator. By collecting data from only those women who present at the facility, the study introduces selection bias and will not be representative of the experiences of the wider population of women who self-administer abortion pills.

Tellingly, there were no deaths or hysterectomies in the series reported and 17.5% of the women analysed required either no treatment of simply additional misoprostol. This indicates that even those women who ended up in the hospital did not suffer major morbidity.

The author’s assertion of an increase in maternal morbidity and mortality is unjustified as there is no baseline from which to calculate such an increase. In fact, it is plausible and perhaps likely that the expanded availability of abortion pills over the counter reduces maternal morbidity and mortality by offering a safer alternative than invasive or violent methods.

The study also suffers from a number of ascertainment issues that make the results difficult to interpret. The authors rely upon women’s self-report of administering “abortion pills” without any validation of what specific pills, doses, and regimens were used. There is also no systematic collection of other remedies attempted. Therefore, the complications seen cannot be directly attributed to the use of mifepristone and misoprostol obtained at pharmacies.

The available data are insufficient to make any conclusions regarding the societal and policy implications of the availability of abortion pills in pharmacies. We cannot rely on this study to inform our understanding of the safety of abortion medications for self-use in India or elsewhere.

Sincerely,

Laura J. Frye, MPH

Beverly Winikoff, MD

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Fifteen years: looking back and looking forward

This September marks the fifteenth anniversary of the approval of the sale of mifepristone for medical abortion in the United States. While women in France have had legal access to mifepristone since 1988, it took the United States somewhat longer to approve the drug. In the late ‘90s, the Population Council took on the responsibility of shepherding mifepristone through the FDA approval process in the United States. Though the approval process was a lengthy one, Mifepristone was finally approved in the year 2000. Initially, predictions about the impact of mifepristone were both dire and ecstatic: women would run rampant, having more abortions than ever, boyfriends would slip mifepristone into their girlfriends’ tea, abortion would become simple and easy, women would have access to abortion without any medical interference, and the politics of abortion would soften. While few of these predictions have come true, medical abortion has made a profound change in both the experience of abortion and the landscape of abortion provision.

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A double-blind randomized controlled trial of mifepristone or placebo before buccal misoprostol for abortion at 14–21 weeks of pregnancy

Objective
To assess differences in outcomes of misoprostol with or without mifepristone for second-trimester abortion.

Methods
A randomized, double-blind, placebo-controlled trial of buccal misoprostol following placebo or 200 mg mifepristone was done in Tunisia among women presenting for abortions at 14–21 weeks of pregnancy between August 2009 and December 2011. Women with a live fetus, a closed cervical os, no cervical bleeding, and no contraindications to study drugs were eligible and underwent randomization (block size 10). Participants returned 24 hours later to receive 400 μg buccal misoprostol every 3 hours until complete fetal and placental expulsion (maximum 10 doses, five per 24-hour period). The primary outcomes were rates of complete uterine evacuation at 48 hours and time to expulsion.

Results
A total of 120 women were evenly randomized to treatment. Complete uterine evacuation at 48 hours was recorded in 55 (91.7%) women in the combined group versus 43 (71.7%) in the misoprostol alone group (relative risk 1.28; 95% confidence interval 1.07–1.53). Mean time to complete abortion was 10.4 ± 6.6 hours in the group who received mifepristone versus 20.6 ± 9.7 hours in the misoprostol alone group (P < 0.001). Side effects were similar in both groups.

Conclusion
Adding mifepristone before misoprostol can improve the quality of second-trimester abortion care by making the process faster.

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Secondary Prevention/Early Treatment of Postpartum Hemorrhage: An Innovative New Model for PPH Management

This one-page document summarizes community-level research showing ‘secondary prevention’ —a novel approach to PPH management whereby only women who bleed more than average after childbirth are given a preemptive treatment dose of misoprostol— to be a feasible non-inferior alternative strategy to universally medicating all women who deliver with prophylaxis.

The article on which this summary is based is published in the British Journal of Obstetrics and Gynaecology (Raghavan et al. 2015) and is available here

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Misoprostol-induced fever and genetic polymorphisms in drug transporters SLCO1B1 and ABCC4 in women of Latin American and European ancestry

AIM:
Misoprostol, a prostaglandin analogue used for the treatment of postpartum hemorrhage and termination of pregnancy, can cause high fevers. Genetic susceptibility may play a role in misoprostol-induced fever.

SUBJECTS & METHODS:
Body temperature of women treated with misoprostol for termination of pregnancy in the UK (n = 107) and for postpartum hemorrhage in Ecuador (n = 50) was measured. Genotyping for 33 single nucleotide polymorphisms in 15 candidate genes was performed. Additionally, we investigated the transport of radiolabeled misoprostol acid across biological membranes in vitro.

RESULTS:
The ABCC4 single nucleotide polymorphism rs11568658 was associated with misoprostol-induced fever. Misoprostol acid was transported across a blood-brain barrier model by MRP4 and SLCO1B1.

CONCLUSION:
Genetic variability in ABCC4 may contribute to misoprostol-induced fever in pregnant women. Original submitted 21 January 2015; Revision submitted 24 April 2015.

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  • Topic: Postpartum hemorrhage
  • Type: Staff Publication
  • Author: Alfirevic, A., Durocher, J., Elati, A., León, W., Dickens, D., Rädisch, S., Box, H., Siccardi, M., Curley, P., Xinarianos, G., Ardeshana, A., Owen, A., Zhang, J.E., Pirmohamed, M., Alfirevic, Z., Weeks, A., Winikoff, B.
  • Published: June 2015

Outpatient medical abortion is safe and effective through 70 days gestation

Data show that an outpatient regimen of 200-mg mifepristone followed by a single dose of misoprostol is safe and effective for medical abortion for up to 70 days from last menstrual period (LMP). However, many clinics only provide services up to 63 days LMP, and some practice guidelines do not recommend the higher gestational age limit. Updating clinical protocols and revising the Food and Drug administration label for Mifeprex® to change the indication for termination of pregnancies through 70 days LMP will give women more choices and expand access to safe abortion services. Revising the mifepristone label would protect women against antiabortion legislation that requires adherence to an outdated FDA label, and potentially expand access by encouraging the 30% of U.S. physicians who currently do not provide abortions beyond 9 weeks to serve women in later gestation.

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Reaching women where they are

The requirement that every woman desiring medical abortion must come in person to a clinical facility to obtain the drugs is a substantial barrier for many women. To eliminate this requirement in the United States, two key components of the standard initial visit would need to be restructured. First, alternatives to ultrasound and pelvic exam would need to be identified for ensuring that gestational age is within the limit for safe and effective treatment. This is probably feasible: for example, data from a large study suggest that in selected patients menstrual history is highly sensitive for this purpose. Second, the Food and Drug Administration would need to remove the medically unwarranted restriction on distribution of mifepristone. These two changes could allow provision of the service by a broader range of providers in nontraditional venues or even by telemedicine. Such options could have profound benefits in reducing cost and expanding access to abortion.

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Off-label indications for mifepristone in gynecology and obstetrics

This article examines the off-label uses of mifepristone, and describes how it can be used to treat a variety of reproductive health issues. Currently, mifepristone is only approved to induce abortions during the first trimester. However, it is regularly used to help manage second trimester terminations. Research has shown that mifepristone can also be used to help prime the cervix for labor at term. While it is common practice to use other medications off-label, access to mifepristone in the United States has been severely limited by states’ mandates that mifepristone be used strictly in accordance with the label.

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Misoprostol Added to WHO Model List of Essential Medicines for Treatment of Incomplete Abortion and Miscarriage

The World Health Organization announced the inclusion of misoprostol to its Model List of Essential Medicines based on its proven safety and efficacy for the treatment of incomplete abortion and miscarriage. The judgment was made by an expert committee that evaluated available evidence, which includes several guidelines and numerous randomized and comparative clinical trials for this indication.

The proposal was submitted by Gynuity Health Projects based on the following evidence and considerations:

As described on the WHO website, the Model Essential Medicine List is a guide for the development of national and institutional essential medicine lists. For the past 30 years the Model List has led to a global acceptance of the concept of essential medicines as a powerful means to promote health equity. Essential medicines are selected with due regard to disease prevalence, evidence on efficacy and safety, and comparative cost-effectiveness.

The Model List also forms the basis for medicines selection in emergency situations. Consequently, the EML guides the responses of humanitarian assistance agencies to country requests for assistance in acute emergency settings. Emergency preparedness is facilitated through standardization of medicine and medical supply needs in emergencies, as outlined in The Interagency Emergency Health Kit, and through guidance on appropriate medicines donations as agreed in the Interagency Guidelines on Drug Donations.

The recommended doses for treatment of incomplete abortion and miscarriage are:

Contact .(JavaScript must be enabled to view this email address) or .(JavaScript must be enabled to view this email address) for more detailed information.

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Misoprostol Added to WHO Model List of Essential Medicines for Treatment of Incomplete Abortion and Miscarriage

The World Health Organization announced the inclusion of misoprostol to its Model List of Essential Medicines based on its proven safety and efficacy for the treatment of incomplete abortion and miscarriage. The judgment was made by an expert committee that evaluated available evidence, which includes several guidelines and numerous randomized and comparative clinical trials for this indication.

The proposal was submitted by Gynuity Health Projects based on the following evidence and considerations:

As described on the WHO website, the Model Essential Medicine List is a guide for the development of national and institutional essential medicine lists. For the past 30 years the Model List has led to a global acceptance of the concept of essential medicines as a powerful means to promote health equity. Essential medicines are selected with due regard to disease prevalence, evidence on efficacy and safety, and comparative cost-effectiveness.

The Model List also forms the basis for medicines selection in emergency situations. Consequently, the EML guides the responses of humanitarian assistance agencies to country requests for assistance in acute emergency settings. Emergency preparedness is facilitated through standardization of medicine and medical supply needs in emergencies, as outlined in The Interagency Emergency Health Kit, and through guidance on appropriate medicines donations as agreed in the Interagency Guidelines on Drug Donations.

The recommended doses for treatment of incomplete abortion and miscarriage are:

Contact .(JavaScript must be enabled to view this email address) or .(JavaScript must be enabled to view this email address) for more detailed information.

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Misoprostol added to the WHO Model List of Essential Medicines for the Treatment of PPH

This news section describes the addition of misoprostol for the treatment of postpartum hemorrhage (PPH) to the World Health Organization’s 19th Model List of Essential Medicines (EML) in 2015.

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Misoprostol added to the WHO Model List of Essential Medicines for the Treatment of PPH

This news section describes the addition of misoprostol for the treatment of postpartum hemorrhage (PPH) to the World Health Organization’s 19th Model List of Essential Medicines (EML) in 2015.

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List of Mifepristone Approvals

Gynuity Health Projects tracks the approval of mifepristone throughout the world. This list reflects our latest information about the registration of this medication. If you become aware of registration in new countries, please write to .(JavaScript must be enabled to view this email address) so we can update the list.

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List of Mifepristone Approvals

Gynuity Health Projects tracks the approval of mifepristone throughout the world. This list reflects our latest information about the registration of this medication. If you become aware of registration in new countries, please write to .(JavaScript must be enabled to view this email address) so we can update the list.

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List of Mifepristone Approvals

Gynuity Health Projects tracks the approval of mifepristone throughout the world. This list reflects our latest information about the registration of this medication. If you become aware of registration in new countries, please write to .(JavaScript must be enabled to view this email address) so we can update the list.

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Early Medical Abortion without Prior Ultrasound

This study looked at a recently published systematic review to examine the potential for using the first date of the woman’s last menstrual period (LMP) as a way to estimate gestational age (GA) in order to establish eligibility for medical abortion. The data support the idea that LMP may be an accurate metric for estimating GA, and that this method is promising and should be further investigated.

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Misoprostol added to the WHO Model List of Essential Medicines for the Treatment of PPH

This news section describes the addition of misoprostol for the treatment of postpartum hemorrhage (PPH) to the World Health Organization’s 19th Model List of Essential Medicines (EML) in 2015.

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Adjunct mifepristone for cervical preparation prior to dilation and evacuation: a randomized trial

This non-inferiority trial compared the procedure times between two groups of women undergoing second trimester surgical abortions. The first group was given one set of osmotic dilators plus mifepristone the day prior to the procedure, while the second group was given two sets of osmotic dilators. Both groups received misoprostol prior to undergoing the procedure. Mifepristone with one set of osmotic dilators and misoprostol did not result in longer procedure times or less cervical dilation than serial (two sets) of osmotic dilators and misoprostol, and has the potential to improve access to second trimester abortion without compromising safety.

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  • Topic: Abortion
  • Type: Staff Publication
  • Author: Shaw, K.A., Shaw, J.G., Hugin, M., Velasquez, G., Hopkins, F.W., Blumenthal, P.D.
  • Published: April 2015

A prospective open-label study of home use of mifepristone for medical abortion in Nepal

This study sought to assess the uptake and acceptability of at-home self-administration of mifepristone for medical abortion in Nepal. The majority of study participants chose to take the mifepristone at home; 98% of these women would recommend home administration to a friend undergoing medical abortion.

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Safety, efficacy and acceptability of outpatient mifepristone-misoprostol medical abortion through 70 days since last menstrual period in public sector facilities in Mexico City

This study assessed the efficacy and acceptability of extending outpatient medical abortion in Mexico City through 70 days’ LMP (one week beyond standard outpatient provision). The overall success rate was very high, and the difference in success between women in the 9th week of pregnancy and women in the 10th week was not statistically significant.

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  • Topic: Medical Abortion
  • Type: Staff Publication
  • Author: Sanhueza Smith, P., Peña, M., Dzuba, I.G., García Martinez, L.G., Aranguré Peraza, A.G., Bousiéguez, M., Shochet, T., Winikoff, B.
  • Published: February 2015

Acceptability and feasibility of phone follow-up with a semiquantitative urine pregnancy test after medical abortion in Moldova and Uzbekistan

This paper reports on a study that evaluated the feasibility and acceptability of telephone follow-up after medical abortion using an at-home semi-quantitative pregnancy test (SQPT) and checklist, and compared this mode of follow-up with traditional in-clinic assessment. The researchers found that this alternative method of follow-up was indeed feasible and highly effective in identifying ongoing pregnancy.

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The introduction of first trimester medical abortion in Armenia

A series of research activities were undertaken in Armenia to assess the introduction of medical abortion. A clinical study found medical abortion to be acceptable, feasible, and highly effective. Follow-up assessments found that all five of the study sites continued to offer medical abortion after the study was completed, with four of the sites achieving high success rates.

Reproductive Health Matters. 2015 Feb;22(44 Suppl 1):56-66.

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Self-Administration of Misoprostol for Prevention of Postpartum Hemorrhage (PPH)

This instructional pamphlet uses both pictures and text to explain the correct use of misoprostol for the prevention of PPH. It was developed as a tool that organizations or health facilities can use to educate providers, families, and women on how to use misoprostol for prevention of PPH.

The pictorial panels are targeted to illiterate and low-literate audience and the descriptive paragraphs serve to explain the pictures and provide supplementary information. The organization or health facility distributing the pamphlet may include their contact information in the space provided at the top of the sixth panel. (If this PDF is not compatible with your Internet browser and the filling of form fields is not supported, please click the button labeled “Open with different viewer.” This should be located in the right-hand corner of your screen.)

Folding instructions:

1. Fold pamphlet length-wise along the dotted-line in the middle of the paper so the pictures and text face out.

2. Then fold the 6 panels along the dotted vertical lines accordion-style, so all panels lay on top of each other with the title panel in the front and contact information in the back (see pdf link called instructions for additional information).

The "text only" version in this language is not currently available.

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Self-Administration of Misoprostol for Prevention of Postpartum Hemorrhage (PPH)

This instructional pamphlet uses both pictures and text to explain the correct use of misoprostol for the prevention of PPH. It was developed as a tool that organizations or health facilities can use to educate providers, families, and women on how to use misoprostol for prevention of PPH.

The pictorial panels are targeted to illiterate and low-literate audience and the descriptive paragraphs serve to explain the pictures and provide supplementary information. The organization or health facility distributing the pamphlet may include their contact information in the space provided at the top of the sixth panel. (If this PDF is not compatible with your Internet browser and the filling of form fields is not supported, please click the button labeled “Open with different viewer.” This should be located in the right-hand corner of your screen.)

Folding instructions:

1. Fold pamphlet length-wise along the dotted-line in the middle of the paper so the pictures and text face out.

2. Then fold the 6 panels along the dotted vertical lines accordion-style, so all panels lay on top of each other with the title panel in the front and contact information in the back (see pdf link called instructions for additional information).

The "text only" version in this language is not currently available.

Download PDF in English

Download

Other Languages Available

Self-Administration of Misoprostol for Prevention of Postpartum Hemorrhage (PPH)

This instructional pamphlet uses both pictures and text to explain the correct use of misoprostol for the prevention of PPH. It was developed as a tool that organizations or health facilities can use to educate providers, families, and women on how to use misoprostol for prevention of PPH.

The pictorial panels are targeted to illiterate and low-literate audience and the descriptive paragraphs serve to explain the pictures and provide supplementary information. The organization or health facility distributing the pamphlet may include their contact information in the space provided at the top of the sixth panel. (If this PDF is not compatible with your Internet browser and the filling of form fields is not supported, please click the button labeled “Open with different viewer.” This should be located in the right-hand corner of your screen.)

Folding instructions:

1. Fold pamphlet length-wise along the dotted-line in the middle of the paper so the pictures and text face out.

2. Then fold the 6 panels along the dotted vertical lines accordion-style, so all panels lay on top of each other with the title panel in the front and contact information in the back (see pdf link called instructions for additional information).

A "text only" version is available for users with slower internet connections.

Open Text Version in New Window

Download PDF version:

Download

Download eBook version:

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Sony Reader.

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Knowledge of Abortion Laws and Services among Low-Income Women in Three United States Cities

This paper reports on a survey administered to low-income and minority women to assess their knowledge of abortion laws and services. First-generation immigrants and primarily Spanish speakers were less likely to have correct knowledge than higher-generation or primarily English speakers. More efforts are needed t about abortion, particularly among migrant women and non-primary English speakers.

J Immigrant Minority Health. 2014 Dec 9. [Epub ahead of print]

Access the abstract at: http://www.ncbi.nlm.nih.gov/pubmed/25488893.

Emergency Contraception: A Last Chance to Prevent Unintended Pregnancy

This paper provides a broad overview of emergency contraception. Topics covered include specific methods and regimens, efficacy, side effects, mechanism of action, and population impacts.

Mortality of induced abortion, other outpatient surgical procedures, and common activities in the United States

In response to a multitude of new legislation in the U.S. regulating induced abortion in the guise of protecting women’s health, the authors compared abortion-related mortality to mortality associated with other outpatient surgical procedures as well as some nonmedical activities. Induced abortion in the U.S. is extremely safe and these efforts to regulate it only impede access and potentially harm women.

Contraception 2014 Nov;90(5):476-479.

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Hormonal contraceptive methods and risk of HIV acquisition in women: a systematic review of epidemiological evidence

This systematic review commissioned by the WHO updates a review published in 2012 that assessed whether hormonal contraceptives affect the risk of HIV acquisition. As in the original review, the data do not suggest a link between the use of oral contraceptives and increased risk; however, the relationship between progestin-only injectable contraceptives and risk of HIV acquisition continues to be uncertain. Women using injectables should be educated regarding this uncertainty and empowered to use HIV preventative measures.

Contraception. 2014 Oct;90(4):360-90.

Access the full text at: http://www.contraceptionjournal.org/article/S0010-7824(14)00571-X/fulltext.

  • Topic: Contraception
  • Type: Staff Publication
  • Author: Polis, C.B., Phillips, S.J., Curtis, K.M., Westreich, D.J., Steyn, P.S., Raymond, E., Hannaford, P., Turner, A.N.
  • Published: October 2014

DMPA and HIV: do we need a trial?

The relationship between the use of progestin-only injectable contraceptives and the risk of HIV acquisition remains unclear. In this Editorial, the authors discuss the state of knowledge, current research, and the conflicting views of experts. One key issue is whether or not a trial- one designed specifically to examine this relationship- is warranted. The authors present the practical problems with undertaking such a study, and call for much greater discussion on the topic.

Access the full article at: http://www.contraceptionjournal.org/article/S0010-7824%2814%2900611-8/fulltext.

What happens when we routinely give doxycycline to medical abortion patients?

In some settings, antibiotics are routinely prescribed following medical abortion. This study compared side effects among women who received doxycycline to those who did not and evaluated adherence to one prescribed regimen. Adherence was found to be moderate; women who were prescribed doxycycline reported significantly more vomiting than their counterparts.

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Induction of labour in preeclamptic women: a randomised trial comparing the Foley balloon catheter with oral misoprostol

Between 40,000 and 80,000 pregnant women die each year from pre-eclampsia and eclampsia. While the only cure for these conditions comes with delivery, there are two low-cost interventions commonly used in low-resource settings: oral misoprostol tablets and transcervical Foley catheterization. This randomized, open-label, control trial compared the efficacy, safety, acceptability and cost of those interventions. These methods were compared by assessing and comparing the speed of induction of vaginal delivery, neonatal morbidity and mortality, and maternal complications, mortality and morbidity.

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  • Topic: Preeclampsia
  • Type: Staff Publication
  • Author: Bracken, H., Mundle, S., Faragher, B., Easterling, T., Haycox, A., Turner, M., Alfirevic, Z., Winikoff, B., Weeks, A.
  • Published: September 2014

Claims of misoprostol use based on blood sampling should be viewed with skepticism

In this Special Communication, the authors warn against the validity of any claims regarding the existence of misoprostol in bodily fluids. Several women have recently been prosecuted for induced abortion based on allegations that they took misoprostol; however, these claims are dubious based on the timing required for accurate assessment as well as the arduous and costly procedures involved with lab testing to determine the presence of misoprostol. Therefore, a high level of scrutiny is needed to substantiate any such claims.

Int J Gynaecol Obstet. 2014 Aug 27. pii: S0020-7292(14)00432-9. doi: 10.1016/j.ijgo.2014.08.006. [Epub ahead of print]

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What some women want? On-demand oral contraception

OBJECTIVE:
To summarize evidence regarding current demand for on-demand oral contraception.

STUDY DESIGN:
We used Medline and collegial contacts to find published and unpublished studies conducted or reported in the past 15 years with information assessing women’s interest in using any oral drug preparation, including emergency contraceptive pills, in a coitus-dependent manner either repeatedly or as a primary or planned pregnancy prevention method.

RESULTS:
We found 19 studies with relevant information. The studies were conducted in 16 countries. Eight studies provided data on women’s attitudes regarding a coitus-dependent oral contraceptive; all suggested substantial interest in using it. Nine studies assessed actual use of oral tablets on demand for primary contraception. In these studies, 9-97% of women in the analysis populations reported using the pills on demand as main method, although frequency and consistency of use varied. Reported reasons for interest in or use of this contraceptive approach included convenience, ease of remembering, ability to conceal use, lack of coital interruption, and infrequent sexual activity. Three studies were clinical trials of investigational on-demand oral contraceptives which reported Pearl indices ranging from 6.8 to 53 pregnancies per 100 woman-years.

CONCLUSION:
Data from a variety of settings suggest that demand for an on-demand oral contraceptive may be widespread. The effectiveness of this potential method is not established, however. Considering the seriousness of the unmet need for contraception, further development research into the public health benefits and risks of such a method would be worthwhile.

IMPLICATIONS:
Demand for an on-demand oral contraceptive may be widespread. Efforts should be made to further explore the possibility of developing such a method.

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Calibrated delivery drape versus indirect gravimetric technique for the measurement of blood loss after delivery: a randomized trial

This study compared measures of blood loss obtained from two different measurement techniques frequently used in studies focusing on the prevention and treatment of post-partum hemorrhage (PPH). Significantly greater mean blood loss was recorded by the direct than by the indirect measurement technique, suggesting a meaningful difference in blood loss measurement between these two methods.

BMC Pregnancy Childbirth. 2014 Aug 15;14(1):276. doi: 10.1186/1471-2393-14-276.

Access the article at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4141098/.

First experience of the use of misoprostol as post-abortion care in Libreville, Gabon

The aim of this study was to assess the efficacy and acceptability of 400μg of sublingual misoprostol as first-line treatment of incomplete abortion in Gabon. The rate of successful uterine evacuation was very high (95.7%) as was satisfaction among participants (99.3% satisfied or very satisfied). The findings add to the evidence that this regimen can be successfully introduced in low resource settings.

Pan African Medical Journal 18, 301, 14/08/2014

Access the article at: http://www.panafrican-med-journal.com/content/article/18/301/full/.

Première expérience de l’utilisation du Misoprostol comme soin après avortement (SAA) à Libreville, Gabon.

The aim of this study was to assess the efficacy and acceptability of 400μg of sublingual misoprostol as first-line treatment of incomplete abortion in Gabon. The rate of successful uterine evacuation was very high (95.7%) as was satisfaction among participants (99.3% satisfied or very satisfied). The findings add to the evidence that this regimen can be successfully introduced in low resource settings.

Pan African Medical Journal 18, 301, 14/08/2014.

Link to full article: http://www.panafrican-med-journal.com/content/article/18/301/full/.

Commentary: Evidence versus influence in the WHO procedure for approving essential medicines: misoprostol for maternal health

This letter was written as a response to a commentary stating that misoprostol for PPH prevention was added to the Essential Medicine’s List (EML) not because of evidence supporting its use but because of “influence and vested interest”. Winikoff refutes this argument by citing evidence that supports misoprostol for this use, and by documenting the history of misoprostol advocacy and research that together provide a strong rationale for EML inclusion.

BMJ 2014;349:g4823.

Aceess the link at: http://www.bmj.com/content/349/bmj.g4823/rapid-responses.

Acceptability and feasibility of mifepristone medical abortion in the early first trimester in Azerbaijan

This study examined the acceptability and feasibility of introducing early medical abortion with mifepristone and misoprostol in Azerbaijan. All women were given the option of taking the misoprostol at home, and women in two of the three study sites were also given the option of taking the mifepristone at home. Efficacy and satisfaction were both very high, and a large proportion of women (74% of those eligible) chose home administration of both drugs.

The European Journal of Contraception and Reproductive Health Care, 2014; Early Online: 1–8.

Access the abstract at: http://www.ncbi.nlm.nih.gov/pubmed/25047120.

Efficacy and acceptability of a mifepristone-misoprostol combined regimen for early induced abortion among women in Mexico City

This study aimed to evaluate the experiences of women seeking medical abortion at public sector facilities in a Mexico City district. The mifepristone-misoprostol regimen that was utilized was highly effective and acceptable among study participants.

Access the abstract here.

  • Topic: Medical Abortion
  • Type: Staff Publication
  • Author: Peña, M., Dzuba, I.G., Smith, P.S., Mendoza, L.J., Bousiéguez, M., Martínez, M.L., Polanco, R.R., Villalón, A.E., Winikoff, B.
  • Published: June 2014

Mifepristone plus misoprostol or misoprostol-alone for abortion induction in pregnancies 12 - 24 weeks’ LMP

Gynuity Health Projects convened an expert meeting in 2013 looking at the use of mifepristone and misoprostol for abortion induction in pregnancies 12-24 weeks’ LMP. Professionals with epidemiological, clinical and programmatic expertise reached consensus on the appropriate use of mifepristone and misoprostol or misoprostol-alone for termination of pregnancies with a live fetus. The results were compiled in a brochure called “Instructions for Use – (IFU).” The information in this document may serve as a basis for the development of clinical practice guidelines and patient and provider education materials.

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Decentralizing postabortion care in Senegal with misoprostol for incomplete abortion

This study sought to increase access to post-abortion care (PAC) services at the community level in Senegal by introducing misoprostol as a first-line treatment. Both efficacy and satisfaction with the regimen were very high, demonstrating that this treatment can be successfully provided by lower level clinicians in community health settings.

Int J Gynaecol Obstet. 2014 May 15. pii: S0020-7292(14)00239-2. doi: 10.1016/j.ijgo.2014.03.028. [Epub ahead of print]

Access the abstract at: http://www.ncbi.nlm.nih.gov/pubmed/24893962.

Medical abortion work in Eastern Europe/Central Asia

This summary describes Gynuity’s body of work in Eastern Europe, the Caucasus, and Central Asia.

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Medical abortion work in Eastern Europe/Central Asia

This summary describes Gynuity’s body of work in Eastern Europe, the Caucasus, and Central Asia.

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Download PDF in English

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Medical abortion work in Eastern Europe/Central Asia

This summary describes Gynuity’s body of work in Eastern Europe, the Caucasus, and Central Asia.

A "text only" version is available for users with slower internet connections.

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