Since 2003, Gynuity Health Projects has been at the forefront of efforts to increase women’s access to medical abortion in settings throughout the world, by filling critical evidence gaps, informing clinical guidelines and practice, and forming effective partnerships. We are well-versed in adapting strategies to local contexts and our portfolio encompasses clinical and service delivery research, training and technical assistance, partnerships large and small, policy and advocacy wins, and information and communications efforts targeting a wide variety of audiences.
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 medical 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. Based on initial successful results, the project is expanding to additional states. For more information, visit Telabortion.org or contact us at email@example.com.
Read press coverage about the TelAbortion project here, and consult related resources in our two published TelAbortion articles in Contraception here and here.
Adapting Direct-To-User Telemedicine for Other Contexts
Gynuity is also working to evaluate similar models outside of the U.S. including initiating a pilot study in Mexico, and exploring the feasibility of telemedicine for medical abortion in Ecuador, India and Nepal.
In Mexico, Gynuity has been working 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 medical 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 US TelAbortion (hyperlink telabortion.org) protocol to align with the local conditions and, in April, launched a pilot study to evaluate the acceptability and feasibility of the model in collaboration with abortion service providers in Mexico. As part of this project, we are collaborating with two Planned Parenthood Global partners in southern Mexico. For more information, visit the Clinical Trial database at https://clinicaltrials.gov/, identification No. NCT03931460 or contact TeleILE@gynuity.org.
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.
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 US so far suggested the demand for such a service among women in the US could be substantial. As a next step, we are planning to pilot this model of care in US clinics.
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.
Gestational Age Test Work
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 medical 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 (GA) 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 have identified two protein candidates for a Gestational Age Test and are currently working to confirm these findings in a larger, less-restricted sample of people seeking abortion care.
Simplify and De-Medicalize Medical Abortion Services
Despite its proven safety and efficacy, medical abortion services remain highly medicalized in most settings. Many medically unnecessary restrictions exist on what level of clinician can provide medical 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 medical abortion, improve management of Rh negative women, and to provide medical abortion in the late first trimester (specifically for pregnancies of 11 – 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.
Gynuity is also evaluating the possibility of developing a blood or urine test that could substitute for ultrasound in determining whether a pregnancy is below the gestational age limit for medical abortion. After reviewing the medical literature, we identified 9 pregnancy-specific proteins that may serve as a basis for this test. In our initial exploratory study, we collected serum and urine specimens from 245 women across the entire duration of pregnancy and are in the process of measuring these compounds. Results to date indicate that several appear promising for the proposed test. The next step in this project will be to confirm the preliminary results in a larger and more diverse group of potential users.
Multi-level Pregnancy Tests for Medical 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 medical 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 are working with stakeholders and reproductive technology manufacturers to expand access to this tool.
Expand Access to Medical Abortion in the 1st and 2nd Trimesters of Pregnancy
Gynuity conducts clinical research on gestational age limits for outpatient medical 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 medical 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 medical abortion even further, to 77 days, with a possible adjustment to the regimen.
We are also exploring ways to streamline and increase access to services by developing an evidence base regimen for second trimester medical abortion as an outpatient or 1-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 have 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 medical abortion. We have begun to identify a number of existing medications, currently registered for non-abortion indications, which have promising abortifacient properties. Thus far we have convened an expert advisory group, and have begun 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.
Partnerships for Policy and Practice
Partnerships for Policy and Practice
Collaboration with a range of partners is integral to our model of work. We engage with Ministries of Health, community-based organizations, providers, advocates, pharmaceutical entities, and global norm-setting bodies to amplify our findings and build coalitions for broader change. We aim to realize the promise of medical abortion, and other reproductive health technologies, in the United States and abroad through the activities described below.
Coalition to Expand Access to Mifepristone in the United States
In June 2015, Gynuity launched the Coalition to Expand Access to Mifepristone in the United States (also known as the Mife Coalition), a diverse group of professionals working together to increase public awareness of medical abortion and to expand access to mifepristone medical abortion to all women in the US who need it. Coalition members include researchers, advocates, clinicians, lawyers, and other allies who create collective actions aimed to achieve the goals set by the Mife Coalition’s Roadmap. These actions include research to collect evidence on barriers and challenges in providing mifepristone, advocating on behalf of abortion providers and women to increase access to mifepristone, and promoting public policies and legal actions to improve access to mifepristone, especially among underserved and marginalized populations.
Since its launch, members of the Coalition contributed to the efforts to update the FDA label for Mifeprex (approved in March 2016), advocated (and continue to advocate) through various channels to remove the unjustified restrictions placed on mifepristone, and conducted media outreach and other communications to inform policymakers and the public about barriers to mifepristone access and the need for their removal. By November 2018, 360 individuals who represent 150 organizations had joined the Coalition. A growing Coalition membership moves us toward the goal of ensuring wide availability of mifepristone to women in the US.
Medical Abortion Commodities Database
The International Planned Parenthood Federation (IPPF) worked closely with Gynuity and the Concept Foundation to develop a Medical Abortion Commodities Database. The online resource is open to anyone seeking comprehensive country-level information on quality medical abortion commodities - misoprostol, mifepristone and co-packaged mifepristone and misoprostol (combi packs). As new country-level information about MA products becomes available, the database will be updated. Gynuity continues to partner with IPPF to disseminate the data collected including at technical forums such as the Reproductive Health Supplies Coalition and webinars. We are also conducting an in-depth analysis of medical abortion product inserts to confirm clinical accuracy and identify areas where advocacy is needed with manufacturers, distributors and other suppliers to ensure that correct and consistent information reaches end users.
Introduce Medical Abortion in New Settings
In countries with limited access to health care services and few trained surgical abortion providers, medical methods of abortion hold the promise to help reduce morbidity and mortality. Despite a wealth of published safety and efficacy data on medical abortion, policymakers often prefer locally-generated evidence before registering the medications or including the treatment option in national clinical protocols. We work in a range of settings to expand use of new technologies to other health care facilities, with the ultimate goal of scaling up to a national level.
Incorporating New Clinical Evidence into Service Guidelines
Through leadership and active participation in strategic coalitions (e.g. Reproductive Health Supplies Coalition, Abortion and Post Abortion Care Consortium), working groups, and committees, Gynuity introduces the innovations developed through our clinical research into national and international clinical guidelines that are used in turn to effect change at the institutional level.
We also participate in advisory groups organized by the World Health Organization to create and update guidelines on abortion, such as the 2015 Guide on Health Worker Roles in Providing Safe Abortion Care and Post-abortion Contraception. We have actively collaborated with a multidisciplinary working group, SERAH, created that year to disseminate the guidance in global and regional conferences and webinars.
Expand Medical Abortion Access through Education and Local Champions
Gynuity organizes national and regional forums for women’s health advocates, clinicians, and policy makers on medical abortion to share information and strategize about ways to integrate the method into practice in varied contexts. We train and prepare health professionals to use medical abortion regimens where it is unknown, relatively new, or underutilized. To broaden the impact of our work, we develop clinicians and advocates as local champions of medical abortion. These individuals may be providers who participate in our studies, NGOs that are well connected with the key policymakers, or government officials in Ministries of Health.
Communications for Impact
Communications for Impact
Translation of Critical Evidence for Diverse Audiences
Gynuity synthesizes evidence into user-friendly clinical guidelines and materials for clinicians and women’s health advocates. We frequently call together experts in medical abortion research and form working groups to evaluate, compile and disseminate evidence on promising technologies and service delivery models. The results of these efforts include our and Instructions for Use brochure series that outlines regimen options for early medical abortion and abortion induction with medications in the second trimester, and our Medical Abortion Guidebook.
We also undertake the following activities to expand our reach and make evidence accessible.
- Develop and adapt training curricula for use in seminars and clinical research studies, and for governments and NGOs.
- Conceptualize and coordinate webinars with partners for international and regional audiences and country colleagues to share experiences and evidence.
- Design and produce pictorial materials for low literacy populations to reinforce key messages about how to use medical abortion regimens, accessible via our Image Bank.
- Create instructional videos for use in research and beyond such as the tool for how to use the multi-level pregnancy test (MLPT) after medical abortion.
- Provide information and interviews for print and digital media as well as radio interviews. Gynuity's work on telemedicine models for medical abortion have generated a significant amount of press coverage.
- TelAbortion Media Toolkit
- A Non-Inferiority Study of Outpatient Mifepristone-Misoprostol Medical Abortion at 64–70 Days and 71–77 Days of Gestation
- Sensitivity and specificity of placental proteins for gestational age screening: An exploratory study
- A cross-sectional analysis of mifepristone, misoprostol, and combination mifepristone-misoprostol package inserts obtained in 20 countries
- Mifepristone's Multiple RH Indications: An overlooked Opportunity for Expanding Access
- TelAbortion: Evaluation of a Direct to Patient Telemedicine Abortion Service in the United States
- Efficacy of Misoprostol Alone for First-Trimester Medical Abortion: A Systematic Review
- TelAbortion: a new telemedicine service in the U.S.
- List of Mifepristone Approvals
- Medical Abortion Program Brief
- FAQs on the Use of Multilevel Pregnancy Tests for Medical Abortion
- Increasing Access to Abortion With Telemedicine
- Claims of misoprostol use based on blood sampling should be viewed with skepticism
- Efficacy and acceptability of a mifepristone-misoprostol combined regimen for early induced abortion among women in Mexico City
- Medical abortion work in Eastern Europe/Central Asia
- Acceptability and feasibility of medical abortion with mifepristone and misoprostol in Nigeria
- FAQ on Misoprostol Detection in Blood
- Mife plus miso or miso-alone for abortion induction in pregnancies 12-24 weeks’ LMP
- Acceptability and feasibility of phone follow-up after early medical abortion in Vietnam
- Prophylactic compared with therapeutic Ibuprofen analgesia in first-trimester medical abortion
- Acceptability and Feasibility of Mifepristone-Misoprostol For Menstrual Regulation in Bangladesh
- Simplified medical abortion using a semi-quantitative pregnancy test for home-based follow-up
- Efficacy and acceptability of early mifepristone-misoprostol medical abortion in Ukraine: results of two clinical trials
- Acceptability and feasibility of the use of 400 μg of sublingual misoprostol after mifepristone for medical abortion up to 63 days since the last menstrual period: evidence from Uzbekistan
- First-trimester medical abortion with mifepristone 200 mg and misoprostol: A systematic review
- Medical abortion for adolescents
- Sublingual misoprostol after mifepristone