Gynuity Health Projects

Programs

STIs/HIV/Infectious Disease

STIs/HIV/Infectious Disease Overview

AIDS, the deadly syndrome caused by the Human Immunodeficiency Virus (HIV) is perhaps the highest-profile health problem of recent decades. Despite the emergence of antiretroviral drugs, the disease continues to ravage populations worldwide, disproportionately in sub-Saharan Africa. For both biological and cultural reasons, the disease hits hardest among women and the young: WHO estimates that 30% of the 40 million people living with HIV worldwide are between the ages of 15 and 24, and that, in sub-Saharan Africa, there are 13 women living with HIV for every 10 men.

In addition, although far less serious than HIV infection, vaginal infections are among the most frequent reproductive health complaints of women worldwide. Bacterial vaginosis, yeast infections, and trichomonas are responsible for a large number of clinic visits and a great deal of day-to-day distress among women. The vagina is also a major port of entry for pathogens, and the health of the vaginal environment contributes to women’s resistance to such pathogens. Thus, treatments or preventive measures that can improve vaginal health and reduce the frequency of minor infections may also lower the impact and risk of more serious and potentially life-threatening infections, including HIV.

Through our work in this area, we seek to improve our knowledge of the vaginal environment and its interaction with pathogens, and consequently, to identify avenues for improving women’s reproductive health. Among our approaches is to explore innovative uses of health technologies, such as new uses of established/approved drugs, to improve vaginal health and to decrease the risk and impact of various infections.

Gynuity Activities
  • Clinical research to investigate woman-controlled products for vaginal health.
  • Collaboration with pharmaceutical companies to facilitate the registration of new technologies.
  • Clinical research to investigate the prevalence and correlates of C. sordellii and perfringens carriage among women of reproductive age.
  • Organization of seminars, educational opportunities and training courses.
  • Development of training and educational materials for policymakers, clinicians, and users.

Postpartum Hemorrhage

Postpartum Hemorrhage Overview

Hemorrhage is the largest single cause of maternal death, accounting for about one-fourth of maternal mortality. Misoprostol is promising in two aspects of morbidity reduction:

  • by preventing the onset of postpartum hemorrhage when used after delivery of the placenta as part of the management of the third stage of labor; and
  • by treating postpartum hemorrhage, either after previous prophylaxis has failed or where no prophylaxis has been given.

Misoprostol stimulates uterine contractions, which may effectively prevent or end bleeding after delivery. It may be especially important in settings where no other effective drugs are currently available for prevention or treatment of postpartum hemorrhage.

Gynuity recently completed the first phase of a large-scale project to evaluate misoprostol for postpartum hemorrhage prevention and treatment and to help raise awareness about its potential, especially in low-resource settings where it could have the greatest impact. In November, 2009, The Bill and Melinda Gates Foundation awarded Gynuity a $25 million, 5-year grant to implement a series of new research and advocacy activities building upon the success of the initial project.

Gynuity Activities

Under the new grant, some of the specific research and program approaches in the five-year body of work include:

  • development and implementation of studies to identify pathways for the safe and effective use of misoprostol for PPH prevention and treatment for use outside of tertiary level facilities;
  • development of an evidence-based policy and advocacy agenda in partnership with key international and regional organizations;
  • creation of new clinical knowledge on misoprostol for PPH indications;
  • encouragement of policy change at national and international levels;
  • creation of informational materials for use by various audiences to address issues of access to interventions to prevent and treat PPH; and
  • collaboration with pharmaceutical entities to push for greater availability of misoprostol for PPH care.

Pre-eclampsia

Pre-eclampsia and eclampsia are serious conditions unique to pregnancy and resulting in 40,000-80,000 deaths worldwide each year. In resource-poor settings, treating pre-eclampsia/ eclampsia presents many challenges. Magnesium sulfate, an inexpensive drug, is an effective treatment but has limited availability in the developing world and is potentially harmful to the pre-eclamptic woman and her fetus if its administration is not carefully monitored. For this reason, additional research is needed on new approaches for use of this technology where clinical and human resources are limited.

In collaboration with colleagues in three clinical centers in India, Gynuity is conducting a pilot study that examines the introduction of a different treatment approach for the provision of magnesium sulfate. The overarching goal of this project is to demonstrate the safety of a simple, inexpensive flow controlled pump, SpringFusor. It is hypothesized that the SpringFusor pump may offer a treatment approach that is superior to the current standard of care in terms of accurate delivery of treatment, ease of use, cost-effectiveness, and demands on staff time. A safe and simple system for the IV administration of magnesium sulfate will permit the expansion of its use in pregnant women and into clinical environments where resources do not currently exist to treat with magnesium sulfate prior to delivery or to transfer for more intensive care.

Gynuity Activities
  • Document the profile of serum magnesium concentration obtained with the administration of magnesium sulfate by the new treatment approach and an IM regimen.
  • Develop training curricula for the new treatment approach.
  • Document the acceptability of the new treatment for patients and staff.
  • Identify the strengths and weaknesses of current and proposed new routes of administration.
  • Learn how to measure the time and cost elements involved in providing each method.
  • Demonstrate that lower levels of the health system can safely and effectively manage the provision of magnesium sulfate to women with pre-eclampsia/ eclampsia.

Related Resources

Pregnancy Failure and Miscarriage

Pregnancy Failure and Miscarriage Overview

Of all recognized pregnancies, 15-20% are spontaneously miscarried and an additional 22% end in induced abortion. Incomplete abortion occurs when products of conception are partially expelled from the uterus; and either spontaneous or induced pregnancy loss can result in incomplete abortion. Women seeking care following incomplete abortion are faced with the inadequacy of existing safe abortion and postabortion care services. In countries where access to safe abortion services is restricted, abortions may be performed by unskilled providers in poor conditions and incomplete abortion is of particular concern.

The occurrence of spontaneous fetal death after the first trimester is difficult to ascertain but one estimate is that, in the United States alone, approximately 125,000 to 190,000 2nd- and 3rd-trimester fetal deaths occur each year. Common therapies for 2nd trimester intra-uterine fetal death (IUFD) include dilatation and evacuation surgery and non-surgical labor-induction agents; their use depends in part on gestational age and provider skills and method preference. At this stage of pregnancy, the nonviable fetus is often not spontaneously evacuated, yet timely evacuation is vital in order to avoid the possibility of serious complications for the woman.

We invite you to learn about our approach to pregnancy failure in the first and second trimesters of pregnancy.

Related Resources

Medical Abortion

  1. Medical Abortion Overview
  2. Introduction of Medical Abortion in Developing Countries
  3. Medical Abortion Regimens Improvement
  4. Decrease in Use of Routine Sonography
  5. Misoprostol Alone Regimens for Early Termination of Pregnancy

Medical Abortion Overview

Mifepristone medical abortion requires the use of two drugs: mifepristone and misoprostol. Mifepristone is an antiprogestin taken orally during the first trimester of pregnancy. It blocks receptors of the hormone progesterone. As a result, the lining of the uterus can no longer sustain the growing embryo. The drug also increases prostaglandin levels and dilates the cervix, facilitating abortion. Misoprostol is a prostaglandin analog that is marketed worldwide in over 60 countries for treatment and prevention of gastric ulcers. It is widely used “off-label” for a number of reproductive health indications.

One tablet of mifepristone is swallowed first, causing the embryo to stop growing. Two days later, the woman takes misoprostol, causing contractions of the uterus and expelling the uterine products. The timing, dose, and route of administration of misoprostol often vary slightly. Studies have shown that these drugs effectively terminate more than 9 out of 10 pregnancies in the early first trimester.

Gynuity Activities
  • Demonstration projects using medical abortion regimens to introduce the technology in new settings.
  • Studies to inform service delivery protocols for low resource settings.
  • Collaboration with pharmaceutical companies to facilitate the registration of the drugs internationally.
  • Partnering with large nongovernmental organization service providers to introduce medical abortion.
  • Creation of policy, sharing of information, and advocacy for medical abortion technologies.
  • Organization of seminars, educational opportunities, and training courses to share information and stimulate interest in the technology’s potential.

Related Resources