Response to the COVID-19 Pandemic
The Covid-19 pandemic necessitated urgent modifications of abortion practice. Gynuity convened partners and developed guidance for services providing abortions using mifepristone and misoprostol and/or misoprostol-alone to ensure continued access during the pandemic. Our recommendations are relevant for simplifying care even beyond the pandemic.
Sample Protocol for Increasing Access to Medical Abortion
Aimed primarily at a provider audience with access to both mifepristone and misoprostol, this sample protocol and accompanying commentary published in Contraception offered guidance on the provision of medical abortion without any routine facility-based tests. Planned Parenthood Federation of America (PPFA), the American College of Obstetricians and Gynecologists (ACOG), and the Society of Family Planning (SFP) adopted no test protocols in 2020 and were influenced by our paper. Spanish and Russian translations of the article were disseminated to colleagues in Latin America and post-Soviet states.
Guidance for Providers Offering Misoprostol-Alone for Abortion
Gynuity and the Centro de Estudios de Estado y Sociedad (CEDES) together with multiple other partners developed global guidance for health professionals offering misoprostol-alone for abortion. This resource recommends adjustments in clinical practice to enable safe access to high quality care while limiting unnecessary visits to medical facilities, possibly reducing costs for both abortion-seekers and the health system. Translated into multiple languages, the guidance is available in a traditional printable format and mobile-optimized format suitable for viewing on smart phones or tablets.
"No-Test” Medical Abortion
Pre-abortion ultrasound or pelvic exam can often be a substantial barrier to access. Gynuity and partners conducted a study in the U.S. to assess the safety and efficacy of a “no-test” medical abortion screening process.
The frequent requirement that an individual should have a pre-treatment ultrasound or pelvic exam prior to medical abortion has become a substantial barrier to access. During the COVID-19 pandemic, some clinics in the U.S. began offering medical abortion without these tests; eligibility for the service was evaluated solely by client history.
Gynuity collaborated with the University of California, San Francisco and multiple other partners to conduct a retrospective study assessing clinical outcomes of this "no-test" screening process. We collected data from about 4,000 such abortions provided by clinics in the U.S. Analyses suggests that history-based assessment does not compromise safety or efficacy. A paper was submitted for publication.
We expected that our results will be of interest to the U.S. Food and Drug Administration (FDA) during its planned reconsideration of the current restrictions on distribution of mifepristone. We hope the FDA will promote policies to simplify access to medical abortion, reduce its cost, increase the types of providers and venues that can offer it, and enhance user safety and autonomy during this pandemic and beyond.
Later First Trimester Medical Abortion
Medical abortion is increasingly used as an outpatient alternative to aspiration, but lack of formal evidence has limited its offer beyond 10 weeks of pregnancy. We were awarded a grant to explore further the evidence for the most effective medical abortion regimen at 11 and 12 weeks.
In 2020, the Society of Family Planning awarded Gynuity a grant to study the impact of an additional dose of misoprostol for mifepristone-misoprostol abortion at 71-77 and 78-84 days (11 and 12 weeks) of gestation with six clinic partners in the U.S.
This work to expand the evidence base for the most effective medical abortion regimens in the later first trimester of pregnancy builds on our prior published research in this area – including two studies that evaluated the success of medical abortion regimens in the 11th week of pregnancy.
The first study demonstrated very good success using the standard first trimester outpatient regimen (mifepristone 200mg followed by misoprostol 800mcg 24 to 48 hours later).
The second study examined retrospectively data from medical charts of people in the 10th and 11th weeks of pregnancy who had outpatient medical abortions with mifepristone and two doses of misoprostol 800mcg instead of one.
The evidence from these studies served as the basis on which the National Abortion Federation expanded its 2020 Clinical Policy Guidelines to recommend outpatient medical abortion through to 11 weeks.
Second Trimester Medical Abortion
Service delivery models for second trimester medical abortion frequently include hospital admission and overnight stays, which can be burdensome and undesirable, as well as costly. We launched a study with our partner in Nepal to evaluate a one-day service for second trimester medical abortion.
Gynuity and CREHPA launched a study to evaluate the practicality of a one-day medical abortion outpatient service for second trimester abortions in two public sector hospitals outside the Kathmandu Valley. This research included a cost analysis of the one-day procedure that will be helpful for decision-makers.
The findings will provide insight into the feasibility of this streamlined model of care to meet the needs of more people and expand access to second trimester abortion services for high volume and under-resourced facilities around the world.
Our study builds on earlier published research in three private hospitals in Kathmandu, which found this model of later abortion care to be safe, effective and feasible when offered by various levels of health care providers.
Telemedicine for Medical Abortion
Early medical abortion delivered through telemedicine has the potential to improve access to care by increasing the reach of providers and offering individuals the option of obtaining care without an in-person consultation. Since the launch in 2016 of Gynuity’s TelAbortion study in the U.S., our work has continued to grow geographically, with technical assistance, strategy development and implementation research.
Social distance mandates, increased childcare demands, fear of exposure to the virus, and enforced stay-at-home measures due to possible or confirmed coronavirus, introduced new barriers to obtaining medical abortions in the U.S. Our TelAbortion study, the first direct-to-user telemedicine abortion service in the country, saw usage double during the height of the pandemic, with numerous participants reporting this service as their only option for care.
In 2020, we mailed nearly 900 TelAbortion medication packages to study participants, and added five locations to expand the service area to a total of 14 states and D.C.
The study was featured in many mainstream media outlets including The New York Times, Vice, Huffington Post, The New Yorker, Refinery29, and Full Frontal with Samantha Bee.
Temporary changes to mifepristone regulations during the pandemic enabled us to implement rapidly a parallel study that extended the gestational age limit to 77 days and allowed provision of medical abortion without a pre-treatment ultrasound. Data from the TelAbortion study will contribute to the larger Gynuity study to evaluate outcomes of “no-test” medical abortion at 15 sites across the U.S. (see above, “No Test” Medical Abortion).
As COVID-19 spread in Mexico, Gynuity added new collaborators to TeleAborto, our medical abortion telemedicine protocol there. To date, over 300 abortion-seekers received care, reporting residences in all 32 states. An interim analysis demonstrated a high level of safety, efficacy and acceptability of TeleAborto. The majority of participants lived more than 150 kilometers from the abortion provider, highlighting the utility of remote service models. Read more about future plans.
Eastern Europe & Central Asia
Gynuity provided technical support and conducted implementation research on telemedicine models in Moldova and the Republic of Georgia, with good outcomes and important learnings. In Moldova, over 500 people were enrolled in a telemedicine abortion study that informed a policy decision to incorporate telemedicine services in the national abortion standards in 2020. In the Republic of Georgia, a demonstration study of 122 participants reduced in-person medical abortion visits from three to one, enabling eligible individuals to receive abortion pills by mail and assess medical abortion success using a multi-level pregnancy test. Data will be used to inform national guidelines. The project included an assessment of reproductive health needs of internally displaced persons, a tool that can be adapted for other contexts. Also in 2020, Gynuity conducted a landscape analysis in Ukraine and Uzbekistan of medical abortion clinical practice, regulations on provision of telemedicine services, and provider attitudes towards use of telemedicine for medical abortion.
Missed Period Pills
Missed period pills are medications to induce menses and ensure a person is not pregnant. This concept is similar to “menstrual regulation” (currently used in Bangladesh) where abortion medication is used when menses is absent. We undertook initial work examining the acceptability of this concept and initiated clinical studies exploring possible regimens for treatment of missed menses.
We continued to lead and convene regular meetings of the Working Group on Missed Period Pills in the U.S. -- which includes clinicians, lawyers, reproductive justice leaders and researchers -- and worked to build support around this concept.
Published results from our U.S. study exploring potential interest in missed period pills show that demand might be substantial and wide-ranging across demographic groups.
In order to generate the evidence needed to effect policy and support the registration of a dedicated pharmaceutical product, we were conducting clinical studies in the U.S. and Mexico on two possible regimens for treatment of missed menses.
Gestational Age Testing
The screening for gestational age using a blood or urine test has the potential to be a simple and cost-effective alternative to pre-abortion ultrasound. We undertook an exploratory study examining a variety of placental proteins to identify the most suitable candidate for such a test.
An exploratory study that collected samples from 245 pregnant people identified two placental proteins, including pregnancy associated plasma protein-A (PAPP-A), as showing considerable potential for a serum test to establish gestational age. We planned to publish in 2021 research comparing different commercially available assays that measure PAPP-A. The findings from this study will help us determine the most promising one for the future development of a point-of-care test.
Task Sharing & Medical Abortion Training
Gynuity is an advocate for widening the range of providers that can deliver safe abortion care. We teamed up with health professionals in Mexico to create and deliver a virtual training on medical abortion care.
We invest in the promotion of mid-level providers and task sharing in abortion service delivery, and seek to expand collaborative efforts to this end globally. In Mexico, we worked with a team of clinical and midwifery professionals to create and deliver an online training on medical abortion care.
The four-module, six-hour course was piloted in December serving over 250 clinicians and reproductive health program managers from Mexico and a dozen Latin American countries. A list of resources compiled for training participants is available here (currently available in Spanish only).
Legal Abortion Services in Chile
Together with the National Abortion Federation, we completed a series of activities with multiple local partners to foster a more favorable environment for legal abortion services in Chile.
We conducted a national survey of physicians and midwives about knowledge, attitudes toward, and practice of legal abortion, as well as in-depth interviews with women, to examine persistent barriers to legal abortion care after liberalization of the law in 2017.
Findings from these studies highlighted the impact of conscientious objection. They complemented evidence from previous research showing that primary care providers lacked knowledge about legal grounds for abortion and national norms for care, which consistently inhibited timely referrals for legal abortion.
We conducted workshops with primary care providers to strengthen proper referrals of eligible women. In response to deficiencies in provider knowledge, we supported development of resources on clinical issues, Chilean law and norms, a summary card of abortion regimens, and a resource for community counselors to provide emotional support.
Contraception & Medical Abortion
Simplifying access to effective methods of contraception for people who have used medical abortion is an important component of high quality abortion care. Gynuity published a toolkit designed to help abortion providers and clinic systems introduce a model of care offering a “one-visit” option to receive a contraceptive at the same time as mifepristone for abortion.
Gynuity’s One & Done toolkit is the product of a pilot project with two family planning clinics. It provides resources and tools to help abortion providers and health care systems introduce a service delivery protocol that allows individuals choosing medical abortion the option to receive an implant or injectable contraceptive at the time of mifepristone administration and to follow up their procedures at home. Simplifying medical abortion protocols and contraceptive access promises to make both options more convenient, available and acceptable.
Congo Red Dot Test for Preeclampsia
As part of our program of work exploring approaches for timely diagnosis and treatment of hypertension in pregnancy, we published results from a collaborative study evaluating a simple urine test for the diagnosis of preeclampsia.
The diagnosis of preeclampsia has traditionally relied on the presence of raised blood pressure (hypertension) and excess protein in urine (proteinuria). The equipment in certain settings to diagnose these indicators can be unreliable, and there may be a lack of trained personnel to use or interpret standard diagnostics.
Research has shown that women with preeclampsia excrete misfolded proteins in their urine. These proteins bind to Congo Red dye (“congophilia”). The affinity of misfolded proteins for Congo Red led to the development of the Congo Red Dot (CRD) test, a simple paper-based urine diagnostic that can be used at the bedside or in outpatient settings.
With the CRD developers and hospitals in Mexico and Bangladesh, Gynuity evaluated the clinical utility and usability of the CRD test for the diagnosis and prediction of preeclampsia during pregnancy and in the postpartum period.
Published results from this prospective, case-control study suggest that urine congophilia can be rapidly identified and that a point-of-care diagnostic for detection of urine congophilia has the potential to improve the triage and diagnosis of patients with preeclampsia.
Misoprostol or Oxytocin for Labor Induction
In 2020, the University of Liverpool, Gynuity Health Projects and GMC Nagpur launched a randomized controlled trial at three hospitals in India to compare use of oral misoprostol to intravenous oxytocin for induction of labor in women who experience hypertension during pregnancy and have undergone cervical preparation with oral misoprostol.
Oxytocin infusions have potential for human error and require constant supervision from experienced staff. In many lower-income countries, neither electronic infusion pumps nor frequent medical attention are available to monitor this treatment.
This study, referred to as the MOLI study (Misoprostol or Oxytocin for Labour Induction), was ongoing and expected to complete enrollment in 2022. Data collection include clinical outcomes for mother and baby, women’s perspectives on their care, and costs related to the induction of labor method used and delivery care.
Misoprostol for Postpartum Hemorrhage
Gynuity worked with partners worldwide to strengthen access to high quality postpartum hemorrhage care in settings where the need for simple, cost-effective and low-tech solutions is greatest. Articles by Gynuity staff and partners published in 2020 provide insights on new models of postpartum hemorrhage care using misoprostol.
In 2020, the World Health Organization incorporated updates to their guidance on postpartum hemorrhage (PPH) -- including on antenatal distribution of misoprostol to pregnant women for prevention of PPH; recommended routes of oxytocin administration for PPH prevention in vaginal deliveries; and, use of uterine balloon tamponade for treatment of PPH. Research findings from studies carried out by Gynuity and partners on these interventions have initiated discussions around needed changes to guidelines.
Several articles by Gynuity staff and partners published in 2020 provided additional data on advance distribution of misoprostol and insights pertaining to implementation considerations for use of misoprostol in home births and at the primary care level for the prevention and management of postpartum hemorrhage.
Mary, M., Jafarey, S., Dabash, R., Kamal, I., Rabbani, A., Abbas, D., Durocher, J., Tan, Y.L., Beverly, W. The safety and feasibility of a Family First Aid approach for the management of postpartum hemorrhage in home births: A pre‑post iIntervention study in rural Pakistan. Matern Child Health J; 2020 Nov 26.
Abbas, D., Mirzazada, S., Durocher, J., Pamiri, S., Bryne, M.E., Winikoff, B. Testing a home-based model of care using misoprostol for prevention and treatment of postpartum hemorrhage: Results from a randomized placebo-controlled trial conducted in Badakhshan province, Afghanistan. Reprod Health; 2020 June 5; Vol. 17(1):88.
Anger, H., Dabash, R., Hassanein, N., Darwish, E., Cherine Ramadan, M., Nawar, M., Charles, D., Breebaart, M., Winikoff, B. A cluster-randomized, non-inferiority trial comparing use of misoprostol for universal prophylaxis vs. secondary prevention of postpartum hemorrhage among community level births in Egypt. BMC Pregnancy Childbirth; 2020 May 24; Vol. 20:317.