Program Highlights

Medication abortion with mifepristone and misoprostol is safe and effective. Although the number of countries with access to mifepristone grows every year, the medication is still not available in many places. Evidence is required to show that another medicine can serve as a viable alternative. Ulipristal acetate has a similar chemical compound and mechanism of action to mifepristone, acting as a selective progesterone receptor modulator, and is commercially available in many countries for emergency contraception.

We undertook a two-stage open-label study at the outpatient clinic of a public maternal hospital in Mexico City to evaluate a new combination regimen for medication abortion using ulipristal acetate.

Sixty-six abortion patients with intrauterine pregnancies through 63 days of gestation were enrolled to compare 60 mg versus 90 mg of oral ulipristal acetate, followed by 800 mcg of buccal misoprostol 24 hours later; the two groups, each comprised of 33 participants, in the preparatory dose-finding study showed similar efficacy and safety profiles. An additional 100 patients were enrolled to supplement the 33 participants who received the 60 mg ulipristal acetate dose, resulting in a total of 133 participants analysed.

Complete abortion with the study regimen was established by ultrasound at the follow-up visit in 129 out of 133 participants (97%; 95% confidence interval, 94.1 to 99.9%). No serious adverse events were reported. Overall satisfaction with the abortion procedure was high, with 130 out of 133 participants rating the treatment as satisfactory or very satisfactory (97.7%).

The groundbreaking results from this proof-of-concept study justify further investigation. We will be launching in 2025 another study to validate the best regimen with the least amount of UPA for the best outcomes. This study will take place in Mexico where a supply shortage of mifepristone has spurred demand for alternative abortion products. The findings will inform the design of a larger multi-country trial.

The project was the subject of a presentation at the 15th International Federation of Abortion and Contraception Professionals (FIAPAC) conference in Belgium.

Service delivery models for second trimester medication abortion frequently include hospital admission and overnight stays, which can be burdensome and costly. In our latest collaboration with CREHPA (Center for Research on Environment, Health and Population Activities), we evaluated the feasibility of an outpatient model for second trimester (13-18 weeks) medication induction.

For this prospective cohort study, participants seeking abortions at two government hospitals were given 200 mg of mifepristone and self-administered 400 mcg of buccal misoprostol 24-48 hours later, one to two hours before returning to the outpatient clinic. Misoprostol was dosed every three hours until expulsion. Participants requiring care beyond outpatient clinic hours were admitted as inpatients.

Conducted in hospitals located beyond the Kathmandu Valley where accredited facilities are dispersed, the study results showed that 82% of the 120 participants avoided hospitalization. The median induction-to-abortion time was five hours. Eleven (9%) participants expelled before clinic arrival. Among those who were admitted as inpatients, none presented clinical concerns or required specialized care. Acceptability among the participants was high.

The two participating hospitals have since introduced the outpatient model into routine care to help reduce crowding in the maternity ward and strengthen the quality of care for all obstetric and gynecology patients. The evidence obtained from this clinical research highlights the efficiency of this new model and could help support a guideline update in Nepal.

“Period pills” involve the use of medicines to empty the uterus for treatment of missed menses without a prior pregnancy confirmation. This treatment could be an alternative form of fertility management useful to individuals with late periods who would be unhappy to be pregnant whether or not they had been pregnant.

Building on the insights from a pilot study evaluating a new “period pills” regimen using medicines currently registered and available in Mexico, our next step is to find the best combination of medications to use for this purpose. Preparation for a larger randomized trial was in progress to assess differing regimens. We continued to support the clinical sites in Mexico to ensure everything was in place to start the enrolment process in 2025.

In 2019, Gynuity Health Projects established a working group on period pills in the U.S. comprised of individual and organizational members with clinical, legal, research, and advocacy expertise.

Hypertensive disorders that occur during pregnancy carry risks for women and are a leading cause of maternal death. Many of the deaths could be prevented by timely and effective delivery. Cost-effective and sustainable induction of labor methods are needed to improve maternal and perinatal outcomes, especially in busy or low-resource environments.

With partners, we published the clinical results from a randomized trial comparing oral misoprostol alone with oral misoprostol followed by intravenous oxytocin to induce labor in women undergoing treatment for pregnancy-related hypertension at three large government hospitals in and around Nagpur. There were similar cesarean section rates (misoprostol 32% v. oxytocin 27%), the primary outcome, among the 520 participants randomized to continue taking oral misoprostol or switch to intravenous oxytocin infusion if they experienced inadequate contractions after taking misoprostol to prepare the cervix for vaginal delivery. (See here for prior research by the same group of researchers on misoprostol as a method for cervical ripening.) There were no cases of uterine hyperstimulation, a potential complication of induced labor, or significant adverse events in either group.

Another paper was published exploring use of a tool to understand research participants’ experiences and satisfaction with care in childbirth. Incorporated into the randomized trial, a pilot study assessed the feasibility and acceptability of the Participant Generated Experience and Satisfaction (PaGES) tool, which asks participants to state freely what is important before and after birth and then asks them to rate the importance of each statement and describe their satisfaction with it after delivery. Interviews with patients showed that they valued the opportunity to be consulted.

Women are at a heightened risk of developing a serious complication in the first 24-hour period after childbirth. Too often, low-resource settings do not have adequate health care staff to provide continuous monitoring during this critical period.

In 2024, Streamline Health completed a mock-up of the “ImPoWA” app and began working on the software development and programming of the digital tool. Designed to be accessed via a smartphone, the self-assessment app prompts birth companions to seek immediate assistance if they identify early warning signs and symptoms which might suggest that the woman is unwell or experiencing a health problem in the immediate postpartum period.

We worked with clinical partners in Uganda, a country where mobile phones are increasingly accessible, to develop a protocol and research plans to test the use of the app at a busy maternity hospital in the capital, Kampala. Pregnant women admitted to the hospital can have a birth companion of their choice present for their delivery and till discharge. With additional funding, we hope to be able to test the app in the future.

This project builds off formative work by colleagues at the University of Liverpool who developed and achieved international consensus on 19 critical signs and symptoms that can be easily assessed by mothers and birth companions in health facilities. Despite international calls for development of strategies promoting self-care, none prior to this work had been developed for self-monitoring in the 24 hours after childbirth.