2023 Annual Report

Program Highlights

Telemedicine for Provision of Medication Abortion

Medication abortion provided through a clinical consultation by phone or video call and receipt of the pills in the mail has become far more widespread and better documented since our early work in the U.S. on this model. We continue to demonstrate the benefits of this approach with the introduction and roll out of telemedicine services to suit different contexts globally.

In 2023, we completed projects in Mexico, Ukraine, Uzbekistan and Azerbaijan to introduce and evaluate telemedicine medication abortion services. The results from these studies were favorable, providing evidence that this model is safe, effective, and acceptable among women and providers in these settings. The importance of having services of this kind in place was underscored in each setting for different reasons, ranging from political and environmental situations affecting access to care to personal and practical ones.

In July, we organized a national dissemination meeting with partners in Ukraine to share the results of an introductory study undertaken in Kyiv and Poltava during Russia’s full-scale military operation in the country. More than 400 people registered to attend the virtual event. Following this meeting, our partners in Ukraine remained active in discussions and meetings with government stakeholders to advise on revisions to their national abortion guidelines. Their efforts ultimately led to the policy decision to incorporate telemedicine medication abortion into their updated guidelines.

In October, we attended FIGO’s World Congress in Paris to give an oral presentation on the TeleAborto project, a direct-to-patient telemedicine service offering guided self-managed abortion in Mexico. Building on favorable results from our prior observational study, the presentation shared the latest initiatives to service people from across both Mexican borders (U.S. and Guatemala) and improve access to medication abortion for more vulnerable and indigenous populations in Oaxaca.

We received approval and preparation is underway with partners for a new study to evaluate the feasibility of the provision of telemedicine medication abortion services via private providers in Ecuador. Set to start enrollment in 2024, this latest study will evaluate a misoprostol alone regimen through 12 weeks’ pregnancy, as per their current clinical guidelines. The insights gained as a result of this work should be useful for other settings where mifepristone is not currently available.

Published research added to the ever-increasing body of evidence in support of telemedicine for medication abortion. Adapted for a setting with compulsory waiting periods and performed in the Republic of Georgia, our study examined a more patient-centered strategy involving fewer clinic trips. After in-clinic screening for eligibility, participants received a telemedicine visit during the waiting period and then a package by mail containing abortion pills and multi-level pregnancy tests for at-home use. Almost all (96%) of the participants contacted by phone for a follow-up consultation reported having a successful abortion that did not require further intervention.

Abortion via telemedicine was picked by MIT Technology Review, a trusted source of authoritative and influential journalism on the application of scientific knowledge, as a top technology set to breakthrough into the mainstream and have a real impact on the world in the years to come. We had the foresight to recognize its potential and are very proud to have been at the forefront of early efforts to demonstrate the feasibility of this increasingly popular service delivery option.

Alternative Abortifacients to Further Expand Access to Medication Abortion

Gynuity Health Projects has been conducting exploratory clinical research into existing medications that might be alternatives to mifepristone-misoprostol medication abortion regimens and useful where access to mifepristone is restricted or its supply is interrupted.

A major problem hindering use of safe and effective medication abortion drugs is the lack of availability. A combination of mifepristone and misoprostol is considered most effective for early medication abortion, but access to mifepristone can be limited. Developing an evidence base for potential new abortion medications would help address the unmet need for abortion and expand choice. We have been pursuing possible alternative options.

The results from one pilot study undertaken in Utah were published in 2022—see here. They showed that a one-dose by-mouth regimen of letrozole followed by misoprostol had lower efficacy than desired and did not warrant further investigation.

The promising findings from a second study, completed in September 2023 at abortion clinics in Mexico using an existing registered compound, are expected to be published in 2024. We are planning further research activities.

Period Pills to Induce Menstrual Bleeding

The currently available range of family planning methods leaves an obvious gap for people who may be too late to benefit from emergency contraception, but who are too early to confirm or rule out pregnancy. Gynuity Health Projects is working to develop a new possible “period pills” regimen, a potential option for inducing menstruation following a missed period to ensure a state of non-pregnancy without waiting for a pregnancy test.

We know from prior qualitative research that some people with missed periods do not desire pregnancy confirmation before taking medications that might disrupt a pregnancy. We also believe that the “period pill” approach is another way to promote self-care and would expand reproductive service options. The first step is to find the best combination of existing medications to use for this purpose.

To date, we have conducted research to assess the efficacy, safety, and acceptability of two possible regimens for treatment of missed/late menses. One study was implemented in the U.S. and used mifepristone followed by misoprostol. A second, pilot study performed in Mexico was completed in 2023 testing a new regimen using medicines currently registered and available in the region. Based on the favorable pilot findings, a larger randomized study will be launched in 2024 to assess two regimens for treatment of early missed menses with partner clinics in Mexico. Our hope is that the results from this study will pave the path for policy change and the registration of a dedicated product for period pills.

Computerized Screening for Medication Abortion Eligibility

Building on positive results from prior research on the safety of medication abortion services using history-based screening, counseling via telemedicine, and abortion medication sent by mail, the latest study in the series introduced additional ways of streamlining the process using methods like email and online forms to screen for medication abortion eligibility. Enrollment was complete in early 2023 and the findings were published later in the year.

Providing medication abortion based only on the responses from a programmed self-administered questionnaire is likely to be effective, safe, efficient, and acceptable, according to the findings from a pilot demonstration study conducted by Gynuity Health Projects with Planned Parenthood affiliates in Colorado and Minnesota.

For this study, individuals wanting to manage their own abortion reviewed an informational website about medication abortion and filled out a linked questionnaire programmed to produce a conclusion regarding their eligibility that they then submitted online for review by a physician. After ruling out the need for a real-time clinical consultation or ultrasound, the abortion medications were prescribed and, together with painkillers, anti-nausea pills, a pregnancy test and instruction guide, mailed or collected in person.

Assessing eligibility for medication abortion this way could reduce the cost of the service, increase clinic efficiency, improve quality of care, and enhance access to abortion. A summary of the key findings is available, and includes information on abortion outcome, adverse events, and satisfaction.

The study featured in a commentary for Stanford Impact Labs, a partner and close collaborator on the project, and the results were presented in poster form at the National Abortion Federation’s 46th Annual Meeting.

Gestational Age Testing Using Placental Proteins

Boosted by our past exploratory studies to determine whether selected proteins produced by the placenta could serve as the basis of a gestational age test and alternative to costly options like ultrasound, in 2023 we published findings from a study involving an intended-use population.

In an ongoing collaboration with the University of Illinois, Chicago, the latest study involving an intended-use population in the U.S., confirmed the strong ability of pregnancy-associated plasma protein-A (PAPP-A) to distinguish pregnancies above and below 71 days’ duration and validated the relationship between the placental protein and gestational age.

For this study, we collected blood samples, medical histories and ultrasound-determined gestational age from patients presenting for abortion services, measured how much PAPP-A was in the blood using two different methods, and assessed diagnostic accuracy for predicting gestational age.

At-Home Assessment of Medication Abortion Success

Medication abortion success can be confirmed in a variety of ways either at home or a medical facility. In a study published this year, we assessed whether waiting to confirm medication abortion using a high sensitivity urine pregnancy test at home was clinically acceptable to people accessing care via telemedicine.

Use of high sensitivity pregnancy tests (HSPT) are not recommended until four weeks after medication abortion but can be done at home whereas ultrasound and a blood test can confirm abortion outcome sooner but require a visit to a medical facility.

In our analysis of data from our five-year research project evaluating a service that provided medication abortion by telemedicine and mail in the U.S., we included participants who either planned HSPT at home three to five weeks after treatment (n=1,130) or a facility-based test within two weeks (n=480).

We found that at-home use of HSPT did not result in a higher risk of clinical intervention after medication abortion provided via telemedicine, nor did it delay identification and management of treatment failures. It was associated with modestly more unplanned, abortion-related clinical visits. Notably, participants planning HSPT were much less likely to have a clinical visit for any reason, mainly because they did not go to a facility for the planned follow-up test. This option, the research concluded, is an appropriate follow-up approach after medication abortion.

A poster showcasing the key findings was accepted for presentation at the National Abortion Federation’s 46th Annual Meeting.

Misoprostol-Only for First-Trimester Medication Abortion

Responding to a new demand for information clarifying the role of misoprostol alone for early medication abortion, we published papers on a new protocol, an updated systematic review, and an analysis of patient data from a U.S. provider organization.

Sample Protocol for Clinicians

A team of experts led by Gynuity Health Projects developed a sample protocol intended to serve as guidance for clinicians in U.S. facilities familiar with mifepristone and misoprostol use wishing to offer a misoprostol-only medication abortion through 84 days (12 weeks) of pregnancy. Informed by published data on the effectiveness and safety of misoprostol-only regimens, the protocol was conceived in response to a Texas lawsuit challenging the Food and Drug Administration’s initial approval of mifepristone in 2000. Accompanied by a commentary, the protocol is endorsed by the Society of Family Planning.

Updated Systematic Review and Meta-Analysis

An update (2023) to our prior systematic review and meta-analysis (2019) continues to support the key conclusion that misoprostol-only regimens are effective and safe for early medication abortion and a reasonable alternative in the absence of mifepristone. For this analysis, we reviewed 66 trial groups (comprising 16,354 evaluable individuals), which varied in location, study design, size, treatment regimens, and assessment approaches. Most people (85%) had complete abortion without a procedure or medications beyond the planned misoprostol regimen and extremely few people (at most 0.2%) were hospitalized or given blood transfusion. Among individuals (11,007) allowed to take at least three misoprostol doses, the first consisting of misoprostol (800 mcg) administered vaginally, sublingually, or buccally, the meta-analytic estimate of the failure risk was 11%.

Retrospective Chart Review

Medication abortion with misoprostol-only was safe and produced complete abortion in most patients with follow-up, according to our retrospective chart review undertaken at a U.S.-based provider organization using data obtained over one year during the COVID-19 pandemic. Loss to follow-up was high. Abortion outcome was established for half of the 911 carafem patients who were treated with up to four repeat doses of 800mcg misoprostol every three hours using differing routes of administration: 82% had complete abortion confirmed by test or history and 9% had ongoing pregnancies detected after treatment. Our detailed examination of service data was the subject of an oral presentation at the National Abortion Federation’s 46th Annual Meeting.

Note: While regimens that include misoprostol only are recommended as a suitable treatment option for medication abortion, they are widely acknowledged as less effective than regimens that also contain mifepristone. Compared to mifepristone-misoprostol regimens, treatment with misoprostol only may take longer and pain may last longer, and there is an increased likelihood of continuing pregnancy.

Self-Managed Abortion via the Internet

The digital era is transforming the way some people obtain abortion care. Internet-based organizations have formed to address online demand for abortion pills. In a collaboration between Gynuity Health Projects and Women Help Women (WHW), researchers and grassroots activists partnered to publish results from our analysis of the latter’s worldwide service delivery data.

Our review of data on more than 3000 people from 30 countries who had sought care over a one-year period through WHW’s internet-based service found that self-managed abortion is a process that can be done safely and effectively with community support and without medical supervision.

To better comprehend the demand for online medication abortion and inform service delivery practice, our analysis sought to understand the user profile, evaluate self-reported outcomes and use of other medical services, and assess the overall experience both with the abortion itself and the counseling and care provided by WHW.

Presented for the first time during a panel session on de-medicalizing medication abortion at last year’s International Conference on Family Planning and published this year in an open-access platform, the analysis is intended to be used by researchers, healthcare providers, policymakers, and advocates to inform their work and develop evidence-based strategies that prioritize safe and accessible abortion care.

Gates Open Research spoke to the authors about their research paper, the number one most-read article of 2023 in this platform.

Hypertenstive Disorders in Pregnancy: Induction of Labor With Oral Misoprostol

We have been engaged in a long-term partnership with the University of Liverpool and clinical sites in Nagpur, India to identify treatment strategies for hypertensive disorders in pregnancy suitable for use in busy or low-resource environments. In 2023, we presented the promising results from our latest joint project exploring labor induction with oral misoprostol and published the first paper in a series of planned publications.

In April, we held a dissemination event to present results from a randomized trial assessing the use of low-dose oral misoprostol for labor induction in women undergoing treatment for pregnancy-related hypertensive disorders at large government hospitals in Nagpur, India. A recording of the event offers a deep dive into the project studies, including a situation analysis presented by Gynuity Health Projects of current labor induction resources, practices, and guidance in Nagpur and the surrounding area.

E-posters showcasing findings from the situation analysis and a pilot study exploring a new way to capture patient experience during childbirth (see top scoring abstract in hot topics, emerging research/issues) were on display at the RCOG World Congress 2023. Further, we published a paper reporting on the feasibility and acceptability of the PaGES (Participant-Generated Experience and Satisfaction) tool. Interviews with patients undergoing labor induction with misoprostol showed that they valued the opportunity to speak about their expectations and actual experience before and after childbirth. The findings from the clinical trial will be published in 2024.

Self-Care Monitoring App for Newly Delivered Women and Their Birth Companions

Regular monitoring by health facility staff of a woman’s condition immediately after childbirth is recommended but, too often, difficult to achieve in resource-poor settings. We initiated a new collaborative research project in Uganda to develop and evaluate the feasibility of a novel app facilitating monitoring of obstetric complications by women and their birth companions.

In partnership with Streamline Health, a Uganda-based app developer, we began work on a new smartphone app geared towards newly delivered women and their birth companions. Comprised of the written word, an audio description and pictures, the app is designed to prompt a woman and/or her companion to seek immediate assistance if they identify any one of 16 early warning signs and symptoms which might suggest that the woman is unwell or experiencing a health problem during the first 24 hours after childbirth.

Development of the app builds off the formative work completed by partners at the University of Liverpool on an immediate postnatal self-care tool (“ImPoWa”). The project draws on our own prior research, which found that a fifth of women who underwent treatment for postpartum hemorrhage at study hospitals in Uganda had initially identified the heavy bleeding on their own or with support from their birth companions.

Pending final approvals, a small pilot study is planned at a busy maternity hospital in Uganda to assess the app’s ease of use and acceptability to women, birth companions and postpartum ward staff and to explore the accuracy, validity and reliability of the mother’s and companion’s assessments when using the app. The insights gathered from the pilot study will help inform the planning of a future larger study to assess the clinical benefits of using the app.