March 8, 2019 

Greetings,

Happy International Women’s Day! Today we celebrate the many social, economic, cultural and political achievements of women. The day also marks a call to action for accelerating gender parity. At Gynuity, we strive for gender equality by placing the health and well-being of women and girls at the heart of our work and finding ways to strengthen access to high quality reproductive and maternal care for all.

Excessive bleeding remains the most common reason women die when giving birth worldwide. Most deaths from this obstetric complication occur in low- and middle-income countries with limited resources. We have undertaken groundbreaking research in partnership with dozens of local and international collaborators to test viable solutions to the global problem of postpartum hemorrhage (PPH) and to push for simpler, more holistic and more accessible PPH management strategies in settings where options are too few and delays in essential care all too common. In this issue’s Spotlight on… , we shine a light on one important component of our work: the role of misoprostol in extending the reach of PPH care to women delivering in the community and lower levels of health systems. 

We’d love to hear your thoughts on the issues covered in this edition of our Newsletter. Please drop us a line at pubinfo@gynuity.org .
Beverly Winikoff
President
New and Noteworthy
Gynuity launches medical abortion telemedicine pilot study in Mexico
Gynuity has been working to develop a medical abortion telemedicine model for Mexico’s health systems that would increase access to abortion care close to home. This model was developed following a review of national telemedicine and health regulations with collaborators and telehealth experts from public and private sectors. This month, we are training private sector clinics to implement a protocol to assess the safety, acceptability and feasibility of this distance care model. The primary components are:

  • Clinical consultations and administrative interactions by telephone and internet;

  • Medications mailed directly to the woman;

  • Ancillary services, such as tests to confirm pregnancy gestation and abortion completion, received near the woman 

This initiative is an extension of our work in the United States that includes the creation of TelAbortion.org , a medical abortion telemedicine project operating in eight states. We are actively exploring viable models in other contexts.
Gynuity's TelAbortion project featured in The New Yorker
Gynuity's pioneering TelAbortion project is featured in this week's New Yorker . The piece, " The Challenges of Innovating Access to Abortion, " by Sue Halpern, details the benefits of this approach to care and includes interviews with clinic partners as well as with a woman who utilized the service. 
Analysis of second trimester medical abortion studies demonstrates feasibility of day service
Current service delivery models for second trimester medical abortion typically include routine inpatient admission and overnight stays. We examined pooled data from six Gynuity studies to assess whether second trimester medical abortion could be offered as a day service. Our findings support the provision of second trimester medical abortion in a day-clinic setting, especially at 18 weeks' gestation or less. Such a model could increase access to care in many settings. (See link to journal article below.) Indeed, Gynuity has just finished a study in Nepal evaluating the safety, efficacy, and feasibility of this model; preliminary results will be shared with local stakeholders in Kathmandu this April.
Systematic review of misoprostol alone for first trimester medical abortion
Dr. Elizabeth Raymond and colleagues recently conducted a systematic review of available data on the effectiveness and safety of misoprostol alone for medical abortion in the first trimester. They concluded that misoprostol alone is effective and safe for first trimester medical abortion and is a reasonable option for women. (See link to journal article below.)
Reproductive Health Supplies Coalition’s (RHSC) Innovation Fund supports Gynuity to increase mifepristone access
The number of countries with access to mifepristone --a gold standard medication for medical abortion-- grows every year, yet the medication remains unavailable in many countries and out of reach for many populations. Gynuity was awarded a grant from the RHSC Innovation Fund to support efforts to register mifepristone at a country level by emphasizing its wider role as a women’s health medication. More indications will likely lead to increased sales and greater market sustainability, which in turn could generate interest by more pharmaceutical companies. Work began in late 2018 to identify market gaps and potential bottlenecks as well as to assess interest in the registration and commercialization of mifepristone for new indications. A progress update will be given at the RHSC General Membership Meeting in Kathmandu, Nepal (25-28 March).
World Health Organization (WHO) guideline on medical management of abortion
Gynuity took part in the Guideline Development Group, a small multidisciplinary group of external technical experts that contributed to the development of a new WHO guideline focusing exclusively on the medical management of abortion. Published in December 2018, recommendations focus on medical regimens for the management of incomplete abortion, intrauterine fetal demise and induced abortion as well as on the timing of initiation of contraception after medical abortion.
Upcoming Events
Gynuity at RHSC meeting in Kathmandu, Nepal (March 25-28).
Gynuity is an active member of the Reproductive Health Supplies Coalition (RHSC) as co-leaders on two Caucus workstreams: the Anti-Hypertension sub-group within the Maternal Health Supplies Caucus and the Safe Abortion Supplies (SAS) workstream within the NURHT (New and Underused Reproductive Health Technologies) Caucus. Both will hold sessions within the larger Coalition meeting. Join us at these sessions:

  • Gynuity staff will be moderating a panel entitled "What information reaches the end user? Analysis of MA product labels collected globally." This session will include presentations of IPPF’s global medical abortion commodities database and a product insert analysis conducted by Gynuity derived from data collected for this effort.

  • We will be presenting preliminary results from a landscape assessment of the availability and cost of blood pressure monitoring devices and antihypertensive medicines in three countries on the panel “Saving mothers’ lives- fridges, blood pressure monitoring and treatment and stakeholder engagement.”

  • During the Maternal Health Supplies Caucus meeting, we will present the findings of the large trial “Introduction of a uterine balloon tamponade device for postpartum hemorrhage in three low income countries,” as well as a sub-analysis focused on uterotonic use.
Online course for health care providers in Latin America on midwifery and task-sharing
Gynuity’s one-day training developed for public sector health providers in Mexico, Evidence on Midwifery and Task-Sharing for Maternal and Neonatal Health and Sexual and Reproductive Health , has been adapted as an online course. It is conducted in Spanish by a team of multidisciplinary facilitators from Mexico and divided into three modules of 75 minutes each.

The course will be presented twice:
  • Saturdays: May 4, 11, 18 from 11h-12:15h Mexico City
  • Tuesdays: May 7, 14, 21 from 18h-19:15h Mexico City

The course content is broadly applicable to the health work force in Latin America. Please SAVE THE DATES and help us share this information widely with health providers, administrators, and policy makers working in the women’s health arena in your networks. Details about the course and how to sign up are available in Spanish on our website .
New Materials
Task-Sharing Brief
Shortages in specialist providers and an uneven distribution of the health workforce within countries pose significant challenges to many low- and middle-income countries, and impact the health and well-being of women and girls. Sharing tasks and responsibilities among health worker cadres is a known strategy for improving access to high quality reproductive and maternal health care. This brief provides a snapshot of our work to expand options for care for some of the most common causes of preventable maternal mortality and disability through task-sharing.
New Peer-Reviewed Articles
Shochet, T., Dragoman, M., Blum, J., Abbas, D., Louie, K., Platais, I., Tsereteli, T., Winikoff, B. Could second-trimester medical abortion be offered as a day service? Assessing the feasibility of a 1-day outpatient procedure using pooled data from six clinical studies . Contraception. 2019 Jan 10. doi: 10.1016/j.contraception.2018.12.004. [Epub ahead of print]

Raymond, E.G., Harrison, M.S., Weaver, M.A. Efficacy of Misoprostol Alone for First-Trimester Medical Abortion: A Systematic Review . Obstet Gynecol. 2019;133(1):137-147.

Charles, D., Anger, H., Dabash, R., Darwish, E., Ramadan, M.C., Mansy, A., Salem, Y., Dzuba, I.G., Byrne, M.E., Breebaart, M., Winikoff, B. Intramuscular injection, intravenous infusion, and intravenous bolus of oxytocin in the third stage of labor for prevention of postpartum hemorrhage: a three-arm randomized control trial . BMC Pregnancy Childbirth. 2019;19(1):38.

Abbas, D.F., Jehan, N., Diop, A., Durocher, J., Byrne, M.E., Zuberi, N., Ahmed, Z., Walraven, G., Winikoff, B. Using misoprostol to treat postpartum hemorrhage in home deliveries attended by traditional birth attendants. Int J Gynaecol Obstet. 2019;144(3):290-296.

Sheldon, W., Durocher, J., Dzuba, I.G., Sayette, H., Martin, R., Cárdenas Velasco, M., Winikoff, B. Early abortion with buccal versus sublingual misoprostol alone: a multicenter, randomized trial . Contraception. 2019 Mar 1. doi: 10.1016/j.contraception.2019.02.002. [Epub ahead of print]
Spotlight On...
Postpartum Hemorrhage Management: Reaching the Hard to Reach
Uterotonic medicines are essential therapy in the management of postpartum hemorrhage (PPH). Misoprostol’s stability at room temperature, availability in tablet form, and relative low-cost, make it ideal for use in community-based care. Our early clinical research conducted with in-country partners helped establish the safety and efficacy of misoprostol for PPH ( Blum 2010 ; Winikoff 2010 ; Mobeen 2011 ) and paved an important path for rethinking where, how, and by whom PPH can be managed.

We have tested several new models to examine the role of misoprostol in treating PPH in settings where the standard of care is referral only. These approaches include:

  • Administration of misoprostol as a preemptive treatment to women with above-normal blood loss (i.e. secondary prevention or early treatment). Two large community trials conducted in India (Raghavan 2016) and Egypt confirmed secondary prevention of PPH with misoprostol as comparable to the established ‘universal prophylaxis’ only approach and revealed several programmatic and cost advantages, including fewer women medicated and exposed to side effects as well as lower costs (Chatterjee 2016). The findings led to the inclusion of this new indication in FIGO’s guidance on misoprostol use in obstetrics and gynecology (Morris 2017).

  • A strategic reframing of PPH treatment with misoprostol as a “first aid” measure by community providers, alongside referral for higher-level care. Two studies implemented in remote communities have found that the use of misoprostol to both prevent and treat PPH during the same home birth is safe and acceptable to women. Traditional birth attendants (TBAs) in Pakistan (Abbas 2018) and the women themselves in Afghanistan administered the preventive dose. TBAs in Pakistan and Community Health Workers in Afghanistan were able to identify heavy bleeding and safely administer treatment with misoprostol. Barriers to transfer documented in a third study that assessed a strategy of adding misoprostol as PPH treatment to the standard of care (referral) in rural Egypt highlighted the need for first aid measures that can be offered safely by community providers when PPH is suspected.

  • Task sharing timely PPH diagnosis and misoprostol treatment to families as “family first aid” to promote care for women who are likely to deliver at home. A study conducted in an underserved part of Pakistan has shown that dispensing misoprostol pills to pregnant women and their families for use as first aid PPH treatment is safe and feasible.

A consistent finding from these studies has been that women, their families and lay health workers, when given the right tools alongside simple training and counselling, can be trusted to identify excessive bleeding and use misoprostol safely and appropriately for PPH care. Context-specific solutions for PPH management, which meet the needs and realities in each low-resource setting, can and must be made available outside of health facilities if global maternal health targets are to be met. 
A tribute: We end by paying our respects to Professor Bukola Fawole. Dr. Bukola was a staunch advocate for women’s health and a highly regarded researcher both in his home country, Nigeria, and further afield. We were fortunate and grateful to have him as a member of our PPH Research Advisory Group for the past 10 years. We will miss him.
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