Vaginal infections are among the most frequent reproductive health complaints of women worldwide. 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. Through our work in this area, we seek to improve our knowledge of the vaginal environment and its interaction with pathogens, to produce and re-interpret epidemiological evidence, and to identify avenues for improving women’s reproductive health.
UNTANGLING THE RELATIONSHIPS BETWEEN MEDICAL ABORTION, ANTIBIOTICS, AND CLOSTRIDIAL INFECTION
Although very rare, obstetric-gynecologic infections with two species of Clostridia bacteria (Clostridium sordellii and Clostridium perfringens) have resulted in a toxic shock-like syndrome with a high fatality rate. Cases of fatal pelvic clostridial infections have followed miscarriages, full-term deliveries, stillbirths, abortions, and cervical procedures. Between 2003 and 2009, 8 deaths occurred in the U.S. after medical abortion. Although no causal relationship has been established between the abortion medications and the development of clostridial infection, concerns over the deaths prompted changes in the way medical abortion is provided including in some places use of routine antibiotics. The occurrence of these infections continues to fuel misinformation spread by anti-abortion activists.
Gynuity Health Projects conducted work to help fill the information gap on C. sordellii and C. perfringens, medical abortion, and antibiotic use.
We conducted a multi-site study with over 4,000 women of reproductive age to document presence of the 2 species of clostridia bacteria in the vagina and rectum. We found that 3% and 10% of healthy reproductive-aged women tested positive for C. sordellii and C. perfringens, respectively; however, none of these women developed clostridial infection. Presence of the bacteria is transient, and does not appear to be related to pregnancy status, antibiotic use, geographic region, or medical abortion.
We collaborated with RM Alden Research Laboratory to test the susceptibility of 90 strains of C. sordellii and 90 strains of C. perfringens to 10 commonly used antibiotics. There was very little resistance found for most of the standard antimicrobial agents tested, with the exception of doxycycline. Forty-one percent of C. sordellii strains and 53% of C. perfringens strains were resistant to doxycycline.
In response to concerns that vaginal administration of misoprostol might increase susceptibility to reproductive tract infections, we collaborated with researchers at Vanderbilt University to conduct a small pilot study of 15 women to determine the extent to which a single buccal or vaginal dose of misoprostol impairs the immune system. We did not observe significant alteration of mucosal or systemic immunology or vaginal microbial ecology 1 day after administration following either route.
We conducted a comparative study of almost 600 women to look at the side effects experienced by women who were/were not prescribed doxycycline following medical abortion and to assess adherence to the antibiotic regimen. Women in the antibiotics group experienced more nausea and vomiting, and only 28% of them reported taking all the medication as instructed. In the absence of strong evidence that 7 days of doxycycline following medical abortion is effective at reducing serious infections, clinicians should consider whether to routinely prescribe antibiotics.
WOMAN-CONTROLLED ESTROGEN PRODUCTS
Natural fluctuations in hormones during the menstrual cycle result in a thickened vaginal epithelium in the follicular phase that thins during the progesterone-dominant luteal phase. The thinner epithelium is a less effective barrier and could possibly render the reproductive tract more vulnerable to pathogens. In a randomized controlled trial in the US, Gynuity Health Projects investigated the delivery of an estrogen gel to the vaginal mucosa as a means of thickening the vaginal epithelium to enhance natural protections against pathogens and maintenance of beneficial vaginal flora. In a world that still has no effective, widely available woman-controlled means of preventing STIs, including HIV, this innovative approach may contribute to efforts that enable women to protect their reproductive health.
Training and Technical Assistance
RELATIONSHIP OF HORMONAL CONTRACEPTIVE USE TO HIV TRANSMISSION
Concern about a possible association between hormonal contraceptive (HC) use and increased risk of HIV infection has been mounting in recent years. A series of laboratory, clinical and epidemiological studies have contributed to a growing body of evidence that suggests such an association may exist. As of now, however, the association remains speculative, and a causal relationship between HC use and changes in HIV risk has not been established. Given the enormity of the AIDS epidemic, especially among women, and the popularity of HC use in many settings, any evidence that HC use may increase the risk of HIV transmission or contribute to disease progression could be expected to have significant impact on policy and program discussions as well as individual women’s decision making.
In response to this potential problem, Gynuity convened a meeting of top experts in the field in May 2005. The meeting’s purpose was to review existing evidence and reach consensus on implications for reproductive health and HIV programs and future research. The participants concluded that there is evidence suggestive of increased HIV susceptibility with hormonal contraceptive use among female sex workers. However, no basis exists for women in the general population to change their contraceptive behavior. Gynuity continues to be involved in global efforts to explore and advise on this topic to advance women-centered recommendations.
PROVIDING EVIDENCE ON ZIKA INFECTION AND TO U.S. HEALTH CARE WORKERS
In response to the emerging Zika public health crisis, Gynuity organized and sponsored the opening plenary session of the 2016 North American Forum on Family Planning, entitled Zika virus: Technical updates and current controversies in the care of reproductive age women. The session reviewed recommendations for prevention, testing and surveillance of Zika virus in the U.S. It also featured an overview of current evidence for fetal effects and pregnancy outcomes associated with Zika exposure in utero. All of the presentations underscored the importance of access to comprehensive health services, including contraception and abortion, in the midst of this public health emergency. Speakers included: Deborah Kaplan, DrPh, MPH, R-PA, Assistant Commissioner, Bureau of Maternal, Infant and Reproductive Health at the New York City Department of Health and Mental Hygiene; R. Phillips Heine, MD, Professor of Obstetrics & Gynecology and Pediatrics and Director of the Division of Maternal-Fetal Medicine at Duke University; and, Laura Gil Urbano, MD of Orientame Foundation in Colombia. The session was moderated by Monica Dragoman, MD, Medical Associate at Gynuity Health Projects. The session was very well received by meeting participants surveyed at the conference.