2021 Annual Report
© Gabriella Clare Marino on Unsplash
2021
Annual Report
Research informs what we do at Gynuity Health Projects. Through our research, we produce robust data, advocate for progressive policies, and provide technical advice to improve service provision and promote self-care strategies.
Telemedicine: Use of Digital Innovation for Abortion Care Delivery
A Gynuity paper summarizing the growth of the TelAbortion service during the COVID-19 pandemic was a primary data source used in the decision by the U.S. Food and Drug Administration (FDA) to suspend the mifepristone in-person dispensing requirement for the duration of the health emergency. The change to the regulations, made permanent in December, makes it easier to obtain abortion care.
Our study shows that people in the U.S. can be counselled remotely and receive abortion pills by mail in a safe and effective service that offers them privacy and convenience. Outcomes were comparable to in-clinic care, and findings support the assertion that there is no medical reason for mifepristone to be dispensed only in clinics. In some cases, people did not need to visit any facilities to obtain the service, including pre-treatment screening, which was important to controlling the risk of COVID-19 infection.
We were delighted our paper was featured in the Society of Family Planning’s fifth annual list of most discussed reproductive health-related papers in 2021.
We launched the TelAbortion Study in 2016 when people wanting to communicate with abortion providers by videoconference or phone and then receive abortion pills by mail was a newly emerging idea. We completed enrollment in September for this first ever direct-to-user telemedicine abortion service in the U.S. It now serves as a model for how abortion care can be provided through telemedicine.
Reducing Reliance on Ultrasound Prior to Abortion
The use of ultrasound to establish medication abortion eligibility is expensive, must be performed by a trained technician, and is generally provided only in specialized medical facilities. In the year under review, we published a paper that examined the clinical and service delivery implications of omitting ultrasound before medication abortion provision via telemedicine and continued to explore the potential of developing a less expensive, less technical tool to determine the duration of a pregnancy.
Implications Of Omitting Ultrasound Or Pelvic Exam Before Provision Of Medication Abortion
The COVID-19 pandemic created a greater openness to explore the clinical and service delivery implications of omitting ultrasound before medication abortion provided by telemedicine and mail. Our study, comparing participants in the TelAbortion Study (see above) who had pre-abortion ultrasound or pelvic exam to those who did not, shows that the omission of ultrasound or pelvic exam before telemedicine medication abortion provision does not appear to compromise safety or result in more ongoing pregnancies.
Both groups had similar and exceptionally low rates of ongoing pregnancy, hospitalization or blood transfusion. Individuals who do not have an ultrasound or physical exam may be more likely to seek post-treatment care and have procedural interventions.
We conducted an additional study with the University of California, San Francisco and others to evaluate the effectiveness and safety of providing abortion with pills to selected clients based on medical history alone. The findings from this retrospective multicenter study will be released in 2022.
Gestational Age Testing Using Placental Proteins
We continued to explore and develop a new method for evaluating gestational age using placental proteins. We completed a study to confirm the relationship between pregnancy-associated plasma protein-A (PAPP-A) and gestational age in a population of people seeking abortion care. A publication is forthcoming.
Also, we published findings from an earlier study comparing different commercially available assays that measure PAPP-A to determine the most promising one for the future development of a point-of-care test. Our prior exploratory study examining a variety of candidate proteins found that PAPP-A showed considerable promise as a basis for a sensitive and specific serum test for distinguishing pregnancies over 70 days.
Furthering the Evidence for Later First Trimester Medication Abortion
Prior research to establish an evidence base and broaden medication abortion use later in the first trimester of pregnancy proved instrumental during the pandemic, helping pave the way for increased access to care either remotely or with minimal clinic contact. We discussed the issues in detail in a podcast hosted by the medical journal, Contraception.
Supported by a grant from the Society of Family Planning Research Fund in 2021, we developed a protocol and study materials, obtained necessary approvals, and established partnerships in preparation for the launch of a follow-on multi-site study to explore the safety, efficacy and acceptability of a highly promising outpatient regimen for mifepristone and misoprostol abortion at 11 and 12 weeks of gestation.
We will begin enrollment in 2022 with six clinic partners in the U.S. We anticipate the results from this study will strengthen provider and user confidence in the later first trimester method and encourage expanded use in and out of clinics.
Improving Access to Affordable, Quality-Assured Medication Abortion Products
New research by Gynuity Health Projects and the International Planned Parenthood Federation has shown a wide variation in the availability and cost of abortion pills across regions and countries.
The scarce availability of mifepristone and combination mifepristone-misoprostol packs at retail outlets and the limited availability of quality-assured abortion medicines and their high cost are important factors affecting access to high-quality abortion care.
Access to high-quality products with clear and accurate information is an essential way to ensure safe and successful self-managed abortion with pills.
Our previous analysis of package inserts revealed numerous inaccuracies and inconsistencies in several products, including inadequate storage instructions and outdated gestational age limits and regimens.
These findings prompted us to develop in 2021 a checklist outlining the minimum requirements for medication abortion package inserts. The checklist can be used to guide insert reviews and improvements.
Period Pills to Induce Menstrual Bleeding
Period pills are medications that induce bleeding when a period is late. People can choose— if they so desire—to bring on a late period at home without first establishing whether or not a pregnancy exists. This option of ensuring non-pregnancy is formally promoted in some countries as a form of fertility control.
Throughout the year, we advanced the concept of “period pills” (also known as “late” or “missed” period pills), publishing an op-ed in Ms. Magazine and harvesting the knowledge and skills of a group of experts via a Period Pills Working Group. A new website designed to help make access to and use of pills that bring on menses a reality in the U.S. was launched in 2021.
We also continued our work to assess the safety, efficacy and acceptability of medication options for period pills. In the U.S., we are studying the use of mifepristone and misoprostol and in Mexico we are studying a new medication regimen for this purpose.
Mexico: A Positive Shift In The Legal Abortion Landscape
Abortion was liberalized in some countries, including Benin, Thailand, and Mexico. In Mexico, a Supreme Court ruling declaring unconstitutional the criminal sanctions for abortion in Coahuila State set a precedent for lifting legal restrictions on abortion in other states. We are supporting efforts to roll out services in the country.
Since Mexico City first legalized abortion in 2007, we have collaborated closely with the public and private sectors to expand the array of options available and help lay the groundwork for effective service delivery. Examples of our collaboration include introducing medication abortion, training health teams and call center staff, facilitating a transition from misoprostol-alone to mifepristone-misoprostol medication abortion, and advising on evidence-based technical guidelines. Data from our combination regimen medication abortion study, the first study of its kind in Mexico, requiring special approval to import mifepristone, were used in a successful bid to register a local mifepristone product over 10 years ago.
More recently, we completed the first phase of an implementation research project on telemedicine medication abortion intended to increase options for those who cannot or choose not to access in-clinic care. Results are slated for publication in 2022.
Low-Cost Methods of Labor Induction for Hypertensive Disorders in Pregnancy
In 2021, we published a summary of the protocol for a randomized trial underway in Nagpur, India that compares oral misoprostol alone versus oral misoprostol followed by oxytocin for induction of labor in women with hypertension in pregnancy. We expect to complete enrollment next year.
This work is part of a longstanding collaboration with colleagues from the University of Liverpool and the Government Medical College of Nagpur to assess misoprostol’s advantages compared to standard methods used to induce labor. A cost-effectiveness analysis, situational analysis, and a formal qualitative assessment of women’s experience are also planned.
The same team of researchers published the anonymized data of over 600 women with pregnancy-induced hypertension who had cervical ripening with either oral misoprostol or Foley catheter prior to labor induction in two high-volume public hospitals in India.
The dataset, published in 2021, includes variables on maternal and neonatal outcomes as well as maternal satisfaction and costs related to each method and is available in the online database repository ReShare. A meta-analysis using these data was also published in 2021 and affirmed that the choice of method for cervical ripening should be personalized and determined based on several factors, including clinician and patient preferences.
We are proud to be part of this research, which provides a comprehensive assessment of the different methods that are used and available for induction of labor.
Assessing Solutions for Effective Treatment of Postpartum Hemorrhage and Preeclampsia
We published research from a prospective study that explored rates of postpartum infection, reported pain, and experiences with care among women who were managed with and without a uterine balloon tamponade (UBT) for treatment of postpartum hemorrhage (PPH).
This study was part of a larger effectiveness trial on the introduction of the condom-catheter UBT for treatment of PPH in 18 hospitals in Uganda, Egypt, and Senegal.
The findings from both studies point to gaps in care and resources that must be addressed to improve healthcare services, prevent poor outcomes from excessive bleeding, and boost patients’ care experiences. Addressing blood supply shortages and stock outs of routine supplies, as well as ensuring that women are monitored closely and offered medications to alleviate pain during their treatment are important areas that have been identified to improve in services.
The World Health Organization’s updated recommendations on use of UBT for treatment of PPH, released in 2021, highlight many of these issues as service delivery preconditions for offering UBT.
We remain focused on identifying strategies to improve access to timely treatment for PPH and preeclampsia—two important global causes of maternal death. Because of the need for improved postpartum monitoring, we are developing a smartphone app designed to help women and their families easily identify symptoms or signs of potentially serious conditions after childbirth. The app then prompts the woman and/or family to seek care when needed. The monitoring tool will be tested in Uganda at a busy maternity unit where women are commonly accompanied by a birth companion.
This work is expected to further support the important role that birth companions play in the postpartum period and may help overcome gaps in current monitoring practices, especially in maternity units in low- and middle-income countries affected by staffing shortages.
With colleagues from the University of Illinois Chicago, we are planning additional work to understand the feasibility of introducing the Congo Red Test (CRT), a simple urine point-of-care test for early identification of preeclampsia in antenatal care services in Ethiopia and Uganda. We are scheduled to start work on this project in 2022.
Training and Education for Health Professionals
This year, we delivered for the second time a real-time virtual course on medication abortion care to health professionals in Latin America and developed an online abortion eResource intended for audiences of professionals from former Soviet countries.
Supporting Adoption of Task Sharing in Medical Abortion Care in Mexico
As part of our work to support adoption of task-sharing by a wider range of health workers, in 2021, we delivered in real-time a four-module, six-hour training on medication abortion care. Delivered virtually in Spanish, the training was attended by over 250 clinicians and reproductive health program managers in Mexico and other parts of Latin America.
In 2020, we had worked with a team of clinical and midwifery professionals to design the course, which we then delivered virtually for the first time later that same year. Participants received an accompanying reference guide, which lists national laws and clinical guidelines as well as international recommendations and published papers to support use by midwives and mid-level providers of mifepristone and misoprostol for abortion care and uterine evacuation.
Self-Paced Electures on Abortion for Health Professionals in Former Soviet Countries
Together with our local partners and a company that provides continuing professional development for the healthcare community in former Soviet countries, we created a short series of eLectures on first- and second-trimester medication abortion methods and counselling on termination of pregnancy for fetal anomaly. The final eLecture in the four-part, self-paced series was a fireside chat on how abortion stigma can contribute to provider burnout.
Delivered in Russian, the eLectures were viewed more than 3,600 times by over 1,600 participants from 13 former Soviet countries during the six-months they were available online. Participants who completed the course received certificates for continuing education credits.