Medication Abortion

Develop Innovative Service Delivery Systems Through Telemedicine

Many women face significant barriers in reaching an abortion clinic. The time, money, lost wages, and childcare arrangements involved in accessing this basic reproductive right can be a substantial hardship for many women. In 2016, Gynuity launched a project in the U.S. called TelAbortion to evaluate the feasibility and acceptability of a model to provide medication abortion by telemedicine. In this project, women receive counseling via videoconference with an abortion provider, obtain screening tests at facilities close to them, and if eligible, receive mifepristone and misoprostol through the mail. The woman has post-abortion tests at facilities close to her, and a follow-up consultation with the abortion provider. We completed enrollment for this groundbreaking research project in September 2021. Consult related resources in our published articles in Contraception Raymond 2019, Chong 2021, and Anger 2021.

Adapting Direct-To-User Telemedicine for Other Contexts

Gynuity is also working to evaluate similar models outside of the U.S. including initiating a study in Mexico and exploring the feasibility of telemedicine for medication abortion in Ecuador, Moldova, the Republic of Georgia, Ukraine, and Uzbekistan.

In Mexico, Gynuity worked with local experts to conduct a review of the current legal and health frameworks for the provision of health care by telemedicine in Mexico. This review revealed that the necessary conditions exist for a remote model to provide medication abortion services. Such a service could ease access difficulties for people who cannot locate timely appropriate care either because of a lack of providers or distance from health facilities. We adapted the U.S. TelAbortion protocol to align with the local conditions and launched a study to evaluate the safety, acceptability and feasibility of the model in collaboration with abortion providers in Mexico. For more information, consult our related resource Pena 2022 or contact TeleAborto@gynuity.org. Para información en español, sigue este vínculo.

Develop Additional Clinical Indications for Mifepristone

Although the number of countries with mifepristone grows every year, women and girls still lack access to this important medication. Gynuity has been developing indications for mifepristone as a regulatory strategy to get the drug into countries with restrictive abortion laws, where mifepristone is not currently available. Three such indications (missed abortion, intra-uterine fetal death (IUFD) and second trimester pregnancy termination) are legal in many (most) jurisdictions, and therefore drug registration would not pose the same legal problems as registering mifepristone solely for early termination of pregnancy. Gynuity was awarded a grant from the RHSC's Innovation Fund to conduct a landscape analysis that will identify market gaps, bottlenecks and potential country-level opportunities to register and commercialize mifepristone for its other indications. Consult our related resources from 2019 here.

Develop a “Missed Menses Pill”/Menstrual Regulation Method

We are developing a new user-controlled method of fertility control to help women and girls manage missed menses. The concept is similar to menstrual regulation (as currently used in Bangladesh) and involves provision of abortion medication without prior pregnancy confirmation. The results from our initial exploratory work in the U.S. so far suggested the demand for such a service among women in the U.S. could be substantial. Consult Sheldon 2020. As a next step, we are piloting this model of care in U.S. clinics. For more information, visit periodpills.org or listen to this podcast from NPR's Invisibilia team.

Globally, this method is of growing interest as well. We have convened focused groups and a small expert meeting in West Africa where colleagues enthusiastically want to increase access to fertility control methods, including abortifacients, in spite of restrictive laws. The service we have in mind could be offered with either a combined regimen of mifepristone and misoprostol (combi-pack or separately packaged), misoprostol alone or potentially other medicines currently registered and available in the region. The method is appropriate for women of all reproductive ages and may be particularly appealing to persons facing stigma – as a “missed menses pill” could be developed as a choice enabling access to a different type of abortion service. Consult Mary 2022.

Gestational Age Test

Clinicians commonly use ultrasound or pelvic exam to confirm that the duration of a pregnancy is below the accepted limit of 70 days before providing medication abortion. These methods are expensive and invasive, and they require an in-person visit to a facility with trained personnel and requisite equipment. A blood or urine test for estimation of gestational age would be highly beneficial, particularly in low resource settings or when providing abortion care remotely through telemedicine. We have completed an exploratory study to determine whether selected placental proteins could serve as the basis of such a test. We identified two protein candidates for a Gestational Age Test (Raymond 2020 and Buhimschi 2021) and worked to confirm the findings in an intended-use population (Frye 2023).

Simplify and De-Medicalize Medication Abortion Services

Despite its proven safety and efficacy, medication abortion services remain highly medicalized in most settings. Many medically unnecessary restrictions exist on what level of clinician can provide medication abortion, where the medications can be dispensed and administered, and the tests required before the treatment can be obtained. Our research has provided critical evidence on the safety and acceptability of a simplified regimen that peels away these barriers that make it challenging for women to access care.

Gynuity has also been pursuing other avenues of research that also address barriers to abortion access. In addition to those described above, these studies seek to simplify procedures regarding screening for ectopic pregnancy prior to medication abortion, improve management of Rh negative women, and to provide medication abortion in the late first trimester, specifically for pregnancies of 11- and 12-weeks' gestational age.

Reducing Routine Use of Ultrasound

In many settings, women are required to make a minimum of two clinic visits, during which they receive pre- and post-treatment sonography. This is expensive and, in most cases, clinically unnecessary. To address this issue, Gynuity tests different service delivery models that allow women to forgo the pre-abortion ultrasound by relying solely on medical history – a “no touch” approach. We led the collaborative development of a sample protocol (Raymond 2020) for providing medication abortion without any routine facility-based tests either before or after treatment. Consult related resource Upadhyay 2022.

Multi-level Pregnancy Tests for Medication Abortion Follow-Up

Multi-level pregnancy tests (MLPTs) are urine pregnancy tests that estimate the level of HCG in urine within a bracketed HCG range. MLPTs are highly effective when used for medication abortion follow-up and can be administered by the woman herself at home as early as 3 to 7 days after taking the abortion medication. Gynuity has conducted numerous studies to evaluate the application of the MLPT in a range of settings and is working with stakeholders and reproductive technology manufacturers to expand access to this tool. Consult, for example, Anger 2023.

Expand Access to Medication Abortion in the First and Second Trimesters of Pregnancy

Gynuity conducts clinical research on gestational age limits for outpatient medication abortion so that women in the late first trimester might have other options besides surgical abortion. Our research demonstrating the safety and efficacy of outpatient medication abortion through 70 days gestation contributed to a change in the U.S. mifepristone label in 2016 and new policies at U.S. Planned Parenthood and independent clinics. More recently, our findings support extending the gestational age limit for outpatient medication abortion even further, to 77 days, with a possible adjustment to the regimen. Consult our related resources Dzuba 2020 and Dzuba 2020.

We are also exploring ways to streamline and increase access to services by developing an evidence base regimen for second trimester medication abortion as an outpatient or one-day process, which could reduce costs to the health care system and increase women’s satisfaction. Based on promising results of recent studies conducted by our research team and collaborators in multiple countries, Gynuity is evaluating a service delivery model for women in the early part of the second trimester (up to 18 weeks) that allows them to take mifepristone and the first dose of misoprostol at home and receive subsequent misoprostol doses on an outpatient basis. When piloting this model of care in Nepal, we found that most participants achieve a successful abortion on the day of misoprostol dosing and overnight hospitalization is not needed.

Conduct Clinical Research to Develop New Abortion Medications

Clients seeking contraception are offered a range of methods. So too should abortion clients if we are to ensure their rights, choice and access to safe medication abortion. We have begun to identify a number of existing medications, currently registered for non-abortion indications, which have promising abortifacient properties. We convened an expert advisory group, and began work on one product that might work as a stand-alone abortifacient. Our project aims to demonstrate that at least one of these medications is a safe and effective abortifacient that can help fill unmet need for safe abortion products at all levels of care, including self-management. Consult related resource Shochet 2022.