The Division of Maternal-Fetal Medicine at Women & Infants conducts a variety of research to help improve pregnancy outcomes. The following are some of the investigators and their projects:
Brenna Anderson, MD, MS, received a NIH K23 Mentored Patient-Oriented Career Development Award in 2009 to study mucosal immunity in the acquisition of HIV. She was also awarded a Center for AIDS Research (CFAR) developmental grant to study the effect of treatment of trichomoniasis on genital shedding of HIV in South Africa. She is engaged in several research studies examining the immune response to HIV infection and other sexually-transmitted infections, as well as normal vaginal immunology and bacteriology. She has also examined the impact of the novel swine-origin influenza A virus on pregnant women. In 2009, she became the alternate principal investigator for the Maternal-Fetal Medicine Units Network site at Women & Infants. In 2010, the Network approved her multicenter study examining the impact of hyperimmune globulin on the prevention of congenital cytomegalovirus, and she will head the CMV study subcommittee.
Donald R. Coustan, MD, serves as the site principal investigator for the Stillbirth Collaborative Research Network, which was established to examine the epidemiology, clinical correlates, and pathogenesis of stillbirth. The network is engaged in the study of a geographically determined, racially mixed population–based sample of 500 to 700 stillbirths and an age matched sample of pregnancies productive of live infants. Dr. Coustan also serves as the North American Regional Director of the Hyperglycemia and Adverse Pregnancy Outcome (HAPO) study, an international observational cohort study of 25,000 gravidas, the results of which are expected to change the way gestational diabetes is diagnosed throughout the world.
Dwight J. Rouse, MD, is the principal investigator for the NICHD-funded Cooperative Multicenter Maternal-Fetal Medicine Units Network. Along with his co-PI, Dr Brenna Anderson, he will head a multicenter study examining the impact of hyperimmune globulin on the prevention of congenital cytomegalovirus.
The Maternal-Fetal Medicine Units (MFMU) Research Network is a group of 14 centers across the country that work together to perform large multicenter clinical trials. Women & Infants’ Division of Maternal-Fetal Medicine is a member of this group, led by Principal Investigator Dr. Dwight J. Rouse and Alternate Principal Investigator Dr. Brenna Anderson. The MFMU Network has done many important clinical trials, including research on 17 OH progesterone for the prevention of recurrent preterm birth and MgSO4 for the prevention of cerebral palsy. The MFMU studies that are currently underway here at Women & Infants include:
- A Randomized Trial of Fetal ECG ST Segment and T Wave Analysis as an Adjunct to Electronic Fetal Heart Rate Monitoring (STAN) - This study is evaluating the effectiveness of fetal ECG, specifically the ST segment and T wave as a determinant of fetal well-being (acidosis) during labor. Women with a singleton pregnancy who are in labor at 36 weeks or greater are potentially eligible for enrollment. The study will enroll 11,000 women in 14 centers across the country.
- Antenatal Late Preterm Steroids: A Randomized Placebo-Controlled Trial (ALPS) - This study is being done to determine whether administration of antenatal corticosteroids to women with anticipated delivery in the late preterm period (34-36.6 weeks) will decrease the need for neonatal respiratory support. Study participants are given two injections of betamethasone/placebo 24 hours apart. Planned enrollment is 2,800 women across 14 centers.
- A Randomized Trial of Thyroxine Therapy for Subclinical Hypothyroidism or Hypothyroxinemia Diagnosed During Pregnancy (TSH) - Recruitment ended in November 2009, and the study is now in the follow-up phase. Women with subclinical hypothyroidism or hypothyroxinemia were given levothyroxine/placebo in an effort to determine whether early treatment of these conditions improved intellectual ability in the child measured at 5 years of age. Children are followed yearly for five years.
- Assessment of Perinatal Excellence (APEX) - This observational study will look at specific adverse outcomes of 120,000 deliveries in an effort to develop quality markers with which to evaluate obstetrical care. Dates are randomly selected and all deliveries occurring on that date are subject to chart review.
- A Registry Study of Novel Swine-Origin H1N1 Influenza A Virus Among Hospitalized Pregnant Women - This observational study was implemented in the 2009-2010 influenza season to evaluate the outcomes of pregnant women hospitalized with influenza-like illness.
- A Randomized Trial of 17 Alpha-Hydroxyprogesterone Caproate for Prevention of Preterm Birth in Nulliparous Women With a Short Cervix - This study is evaluating the effect of 17-alpha-Hydroxyprogesterone Caproate in reducing the risk of preterm birth in women with a short cervix. Participants are nulliparous women identified to have a cervix of less than 30mm. Weekly injections of progesterone/placebo are given until 37 weeks and delivery outcomes are collected on the mother and baby. The goal is to enroll 1,000 women across 14 participating centers.
- Genomic and Proteomic Network for Preterm Birth Research (GPN) - The research is studying genetic causes of preterm birth. Women are enrolled after delivery of either a preterm infant (20-33 weeks gestation) or a full-term infant at 39 weeks or greater. DNA samples are collected on the mother and infant and a maternal questionnaire is completed.
- Preventing Acquisition of Congenital Cytomegalovirus - The study is a randomized, double-masked, placebo controlled multi-center clinical trial of women at participating MFMU Network clinical centers. Women with evidence of primary CMV infection before 23 weeks gestation will be randomized to monthly infusions of IV CMV hyperimmune globulin (100mg/kg)/placebo to determine if it can lower the rate of congenital CMV infection in children of women diagnosed with primary CMV infection during early pregnancy.
- Prospective Cohort Study of the Role of Mucosal Immunity in Risk of HIV Acquisition During Pregnancy - This study compares specific components of the mucosal immune system in pregnant and non-pregnant women to determine to what extent the protection against HIV infection is impacted by pregnancy. During each study visit, a vaginal exam is performed and cervico-vaginal fluid is collected for analysis. The study will enroll 164 women.