2022 Annual Report

Program Highlights

@Nathan Dumlao Holistic Central Asia Unsplash

Outcomes and Safety of History-Based Screening for Medication Abortion

Published collaborative research shows that screening for medication abortion based on medical history alone is highly effective and low risk, with medications dispensed either in-person or by mail. This approach may facilitate more equitable access to medication abortion by increasing the types of clinicians and locations offering abortion care.

Screening for medication abortion eligibility typically includes ultrasound or pelvic examination. To reduce physical contact during the COVID-19 pandemic, many clinicians stopped requiring facility-based tests before medication abortion, creating an opportunity to re-evaluate their routine use.

In a retrospective multicenter cohort study, data from February 2020 to January 2021 were analyzed for nearly 3,800 racially and ethnically diverse people who had obtained in-person and online from 14 U.S. facilities a medication abortion using history alone to screen for pregnancy duration and ectopic pregnancy risk. The findings published in JAMA Internal Medicine showed that the effectiveness rate (95%) was comparable to studies with pre-abortion screening; major abortion-related adverse events (0.5%) were rare.

After publication, the paper received wide attention from academics, traditional and social media, and other sources, and was featured in a Society of Family Planning top 10 list of most discussed family planning publications of 2022. Two years previously, in 2020, a team of clinicians and researchers led by Gynuity Health Projects published a sample protocol intended to serve as guidance for clinicians wanting to eliminate or reduce tests. The practice of reducing tests was subsequently endorsed by multiple professional associations in the U.S.

Project Partners University of California, San Francisco; Maine Family Planning; RHEDI; University of Hawaii; Planned Parenthood North Central States

MA-ASAP: Asynchronous, Web-Based Provision of Medication Abortion

This year, we developed and began evaluating a computer-assisted online platform that facilitates screening evaluation for early medication abortion without real-time interactions between patient and clinician. Enrollment in our pilot study for the Medication Abortion with Autonomous Self-Assessment Project (MA-ASAP) had neared completion by the end of the year.

Building on our prior research, which showed that medication abortion can be safely provided for select patients without in-person clinic visits or facility-based tests and that abortion pills can be safely delivered by mail, MA-ASAP introduces two additional ways of simplifying the process.

First, real-time clinical interactions are not required for every patient. Screening is instead accomplished using asynchronous communication. Second, the screening evaluation uses an online platform that assesses medical eligibility for early medication abortion.

We developed an informational website about medication abortion with a linked questionnaire that asks relevant screening questions and analyzes the responses. Submitted questionnaires that meet the programmed eligibility criteria are immediately transmitted to clinicians who then review them before the abortion pills are dispensed.

Patients were enrolled in a pilot study implemented at two Planned Parenthood affiliates in Minnesota and Colorado to obtain preliminary data on the safety, feasibility, and acceptability of this model. Initial results show that the online platform was effective in selecting for eligibility and raised no safety concerns. Both patients and clinicians were highly satisfied with this method of virtual care, which has potential to speed up abortion access, especially in settings where access to synchronous care is increasingly limited.

This tool could enable non-traditional professionals such as pharmacists or nurses to screen for abortion. Indeed, the tool could be adapted for use by pregnant people on their own, without a clinician, which could help to improve the safety of self-sourced abortion.

Project Partners Stanford University Impact Labs; Planned Parenthood North Central States; Planned Parenthood Rocky Mountains

Strengthening the Evidence for Extending the Gestational Age Limit for Outpatient Medication Abortion in the U.S.

Sites in the U.S. began actively enrolling in a clinical trial launched this year to assess the efficacy of an outpatient mifepristone-misoprostol combination regimen intended for use beyond 70 days of pregnancy, the current limit set by the U.S. Food and Drug Administration. The study is at the same time examining the side effects profile of the two-step regimen and its acceptability to patients whose pregnancies have a gestational age of 71-77 and 78-84 days.

Abortions done with pills in the U.S. continue to rise, reflecting both the method’s appeal and the ease of providing it without the need for specialized training or equipment.

In the latest of a series of studies to strengthen the evidence for extending the gestational age limit for outpatient medication abortion, we are exploring with more rigor an adjustment to the dosing regimen using 200mg oral mifepristone followed 24 to 48 hours later by two 800mcg doses of misoprostol, taken buccally four hours apart, for pregnancies with a gestational age of 71-77 and 78-84 days.

Enrollment is underway at four clinics in the U.S. An additional two clinics, one in Tennessee and the other in Georgia, had to withdraw from the study owing to the enforcement of post-Roe abortion bans in their states.

Enhanced efficacy and a broader gestational age range would particularly benefit people from commonly marginalized groups who are more likely to detect their pregnancies later and experience delays in accessing facility-based abortion care. It would further benefit people who live far from providers trained to perform uterine aspiration, prefer to avoid aspiration abortion, or experience delays in getting clinic appointments because of surging demand in states where the procedure is still available.

This investigation builds on two published studies, here and here, evaluating the success of combined mifepristone-misoprostol regimens for abortion through 11 weeks (71-77 days) of pregnancy.

Project Partners Planned Parenthood Great Northwest, Hawai'i, Alaska, Indiana, Kentucky (PPGNHAIK); Philadelphia Women’s Center; Planned Parenthood North Central States (PPNCS); Queen's Medical Center (Hawaii)

Nepal: Second Trimester Induction Abortion in a Day-Clinic Setting

Findings from this study support the provision of medication abortion at 13-18 weeks’ gestation in a day-clinic setting and reveal significant cost savings when compared to the standard of care (multi-day hospitalization) for the two participating public hospitals. Our local partner in Nepal was awarded a best poster prize after a presentation describing the project at an international conference for abortion and contraception professionals.

In this pilot study performed in two public sector hospitals, 120 women were given a 200mg mifepristone tablet to take either in-clinic or at home and asked to return to the hospital as outpatients 24 to 48 hours later for misoprostol induction. Repeat doses of 400mcg buccal misoprostol were administered every three hours until the pregnancies were expelled. Women who did not complete the abortion process during outpatient clinic hours were transferred to overnight inpatient care.

The outpatient service was found feasible and highly acceptable. Approximately 8 out of 10 (82%) women achieved a successful abortion on the same day as taking the first dose of misoprostol, thereby avoiding any hospital admission. The rate of abortion completion in the day-care setting would likely increase if clinic opening hours were longer and patients took the first dose of misoprostol one to two hours in advance of their arrival at the clinic. In most instances (79%), abortion was achieved with three doses or fewer of misoprostol, with a median of two doses for successful fetal and placental expulsion. Recourse to surgical intervention was low (5%). Almost without exception, women were happy with the service.

A best poster prize was awarded to the founding director of CREHPA, our partner in Nepal, who presented the project at the 14th International Federation of Abortion and Contraception Professionals (FIAPAC) conference in Latvia. The award recognizes the excellent work by our local partners done at a time when lockdowns and restrictions resulting from the COVID-19 pandemic presented a series of significant challenges for clinical research.

Second trimester medication abortion procedures in Nepal typically require two to three days of inpatient hospitalization and compete for limited beds. A separate costing analysis of the outpatient day service showed significant cost savings when compared to the standard of care—hospital admission and overnight stays—for second trimester medication abortion.

The two participating public hospitals in Butwal and Bharatpur have since integrated the care model into routine practice.

This work builds on our earlier published research in three private hospitals in Kathmandu, which found for medication abortion at 13 to 18 weeks of gestation an outpatient day process to be safe, effective, and feasible when offered by various levels of health care providers.

Project Partners CREHPA; KIST Medical College & Teaching Hospital; Lumbini Provincial Hospital; Bharatpur Hospital

Letrozole and Misoprostol Regimen for Early Medication Abortion

New research published this year showed that a one-dose by-mouth regimen of letrozole followed by misoprostol for early medication abortion had lower efficacy than desired and did not warrant further investigation.

Letrozole has been identified as a potential alternative abortifacient that, in the absence of mifepristone and when taken in combination with misoprostol, was proposed as a possible improvement to a misoprostol-only medication abortion regimen.

In the context of our inquiries on next generation abortifacients, we teamed up with the University of Utah to evaluate the efficacy of a single 30mg oral dose of letrozole followed two days later by an 800mcg buccal dose of misoprostol. A second dose of misoprostol was recommended if there was no bleeding within 24 hours.

Findings from our small pilot study undertaken between January and March 2022 at a health center in Salt Lake City (Utah) showed that efficacy was lower than desired.

Abortion outcome was established for 39 out of the 40 participants who presented with pregnancies of up to 63 days: 29 (74%) had a complete abortion, four (10%) had an incomplete abortion and opted for aspiration, and six (15%) had an ongoing pregnancy. Only three of the 10 individuals who took the second dose of misoprostol did so due to no bleeding. There were no unexpected side-effects or safety concerns. A study summary is available in Spanish.

In May, Gynuity Health Projects staff presented alongside Ipas at a well-attended webinar co-sponsored by the Reproductive Health Supplies Coalition (RHSC) and the Latin American Consortium Against Unsafe Abortion (CLACAI), particularly to share with a Spanish-speaking audience the evidence to date on letrozole and misoprostol for induced abortion.

Project Partners University of Utah; Planned Parenthood Association of Utah

Medications to Induce Menstrual Bleeding Without Prior Pregnancy Confirmation

This year, we continued our program of activities in the U.S. and Mexico to advance the concept and actual use of period pills (medication to bring down a late period without a pregnancy test), an approach that could expand choice and service options for people with a preference for ensuring non-pregnancy without prior pregnancy confirmation. We also published results from a study to assess the feasibility of introducing a medical menstrual regulation service in Senegal.

In 2022, we continued to convene the Working Group on Period Pills in the U.S., which currently has 21 members, and presented at a closed webinar hosted by the Working Group to begin a dialogue with providers and clinicians about this service option. The established NPR podcast, Invisibilia, included clips from an interview with Gynuity Health Projects in an episode dedicated to exploring this method of menstrual regulation within the context of a post-Roe America. We know from our prior research that there would be demand for the service were it to be available in the U.S.

We completed a pilot study to assess the effectiveness and acceptability of a new possible period pill regimen with a partner clinic in Mexico City and will be initiating a larger study of this regimen next year. Also, we published results from a qualitative study implemented in Senegal to assess the feasibility of introducing a medical menstrual regulation service in that country. Findings from six focus group discussions and 34 in-depth interviews with women, youth, and health providers in Kaolack, Mbour, and Thiès showed that women and young people are open to medical menstrual regulation as a way to manage a missed or late period, but its introduction and implementation would be feasible only if policymakers approved and health providers supported the service.

Telemedicine for Remote Provision of Medication Abortion

Our pioneering work evaluating telemedicine for remote provision of medication abortion care in the U.S. provided a template for planning and launching activities to introduce this direct-to-patient service in Latin America (Mexico) as well as in Eastern Europe and Central Asia (Azerbaijan, the Republic of Georgia, Moldova, Ukraine, and Uzbekistan). The knowledge and experience accumulated over the years has allowed us to become a leading provider of technical expertise in this method of service delivery.

TeleAborto: Published Findings Show Guided Self-Managed Abortion is Safe, Acceptable and Feasible in Mexico

A published study shows that guided self-managed abortion is safe, acceptable, and feasible in Mexico when supportive care is provided from a distance. Among the 9 in ten people contacted after receiving phone or videoconference counselling through TeleAborto and abortion pills dispensed by mail, most (93%) reported successfully ending their pregnancies with the medications provided and without further intervention. A summary of the key findings is available in Spanish and English. We are collaborating with public and additional private providers through this ongoing service to reach more vulnerable and remote populations in Mexico.

Project Partners Gineclinic; Centro de Atención Integral a la Pareja; Medieg; RedMyH; Planned Parenthood Global; CENETEC

Uzbekistan: Evaluating Remote Provision of Abortion Care Without Mandatory In-Person Tests

In November, we held a national dissemination meeting with partners in Uzbekistan to share the results from a pilot study evaluating a telemedicine medication abortion service delivery model that omits routine facility-based tests—for e.g., pre-abortion ultrasound and blood tests. The event was attended by close to 150 key stakeholders from the ob-gyn community who enthusiastically welcomed the findings. An analysis of the data collected at the two participating facilities in Tashkent and Bukhara showed this approach to be safe, effective, and highly acceptable to women and providers. We are conducting similar studies in Azerbaijan and Ukraine.

After the meeting, Gynuity Health Projects received a formal letter of appreciation from the Uzbek professional ob-gyn association thanking us on behalf of the association and Ministry of Health for our sustained efforts put in over many years to generate evidence that strengthens and improves safe abortion services in Uzbekistan.

Moldova: Medication Abortion via Telemedicine for Women and Adolescents

Gynuity Health Projects provided technical expertise to local partners in Moldova, helping them design and implement a pilot study that found medication abortion via telemedicine to be a safe and acceptable option. The proportion of complete abortions without surgical intervention (97%) was comparable to findings from similar studies. Nearly all participants (99%) were very satisfied or satisfied with the service delivered through two participating sites, one in the capital city and the other in the northern part of the country that served a more rural community. The study’s preliminary findings informed a policy decision to incorporate telemedicine into national abortion standards in 2020.

Project Partners Reproductive Health Training Center; Women's Health Center ‘ANA’

Labor Induction with Low-Dose Oral Misoprostol for Women with Hypertensive Disorders in Pregnancy

Our ‘MOLI’ randomized trial completed enrollment. In this study, a team from the University of Liverpool, Gynuity Health Projects, and clinical sites in Nagpur, India, tested a simple new protocol using oral misoprostol alone for inducing labor in women with hypertension in pregnancy in India. The findings proved extremely promising and were positively received when presented to Indian stakeholders and in Birmingham, U.K., at the British Maternal and Fetal Medicine Society conference.

A randomized trial conducted across three large government hospitals in Nagpur, Central India, found that continued uterine stimulation using oral misoprostol (25mcg every two hours) in the augmentation phase of labor is safe and effective when compared to the standard protocol of switching to intravenous oxytocin after cervical ripening with low-dose oral misoprostol.

Cesarean birth, the primary outcome, was similar (misoprostol 32% vs oxytocin 27%) in the two groups comprising in total 520 women requiring augmentation after membrane rupture. There was no difference in rates of hyperstimulation, side effects, fetal heart rate abnormalities, or adverse neonatal outcomes. Following oral misoprostol induction, further augmentation with oral misoprostol was deemed acceptable by women.

From August to November, a situational analysis was done to assess current resources, practices, and available guidance on induction of labor in hospitals in Nagpur. The analysis consisted of three research streams: a document review of guidelines on induction of labor; key stakeholder interviews to gather information and opinions about current policies and practices on induction of labor in India; and site assessments and provider interviews at public and private facilities in Nagpur district and five nearby rural districts. This assessment helped pinpoint gaps in resources and policies that should be addressed alongside the dissemination of the MOLI study findings.

Induction of labor is often a critical component of care for hypertensive disorders in pregnancy. Identifying safe and effective strategies suitable for use in busy or low-resource environments is vital for good maternal and neonatal outcomes. This current study builds on prior research by the same group, which established low-dose oral misoprostol as an optimal method for cervical ripening—a method strongly recommended by the World Health Organization.

Project Partners University of Liverpool; All India Institute of Medical Sciences, Nagpur; Government Medical College, Nagpur; Daga Memorial Women’s Hospital; Mahatma Gandhi Institute of Medical Sciences

Congo Red Test for Identification of Preeclampsia

We worked closely with the University of Illinois, Chicago and research partners in Ethiopia and Uganda providing technical support in preparation for the successful launch of a multicenter implementation study. The study sets out to understand the feasibility of introducing the Congo Red Test (CRT), a diagnostic screening tool for early identification of preeclampsia, in antenatal care services.

Building on our prior research performed in tertiary hospitals in Mexico and Bangladesh, the study seeks to generate insights that will help inform the development of a triage protocol for antenatal care clinics to help identify and rule-out cases of preeclampsia using the CRT. If successful, this initiative could serve as a model for adoption in other settings. We expect the results to become available in 2023.