In 2023, Baylor College of Medicine’s Department of Obstetrics and Gynecology became a member of the National Institutes of Health/National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network – the first new clinical center activated in 14 years.
Established in 1986, MFMU is the premier multicenter clinical trials network for maternity-related studies. The network hosts maternal-fetal medicine and obstetric clinical trials with two primary goals:
- Reduce maternal, fetal, and infant morbidity associated with preterm birth, fetal growth abnormalities, and maternal complications
- Evaluate clinical interventions for mother and baby, resulting in improved evidence-based, cost-effective obstetric practice
Supported by the National Institutes of Health (NIH), the MFMU Network produces some of the most influential research studies published in the most prestigious medical journals, helping to change public policy and patient care guidelines to reduce maternal morbidity and mortality around the globe.
Dr. Catherine Eppes is the principal investigator (PI) of the MFMU. She is an associate professor in the Division of Maternal-Fetal Medicine in the Department of Obstetrics and Gynecology and serves as the division chief.
Active MFMU Studies at Baylor College of Medicine
Continuous Positive Airway Pressure (CPAP) for Sleep Apnea in Pregnancy (SLEEP)
Emerging data support a link between sleep disordered breathing (SDB) and adverse pregnancy outcomes. In particular, women with obstructive sleep apnea (OSA) appear to be at increased risk of both hypertensive disorders of pregnancy and gestational diabetes. In the non-pregnant population, OSA is typically treated with continuous positive airway pressure (CPAP) during sleep and has been shown to reduce blood pressure in hypertensive patients. Unfortunately, data on whether maternal and neonatal outcomes could be improved with treatment of OSA during pregnancy are extremely limited. This study aims to address this knowledge gap.
A randomized controlled trial of 1,500 women to assess whether treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP) in pregnancy will result in a reduction in the rate of hypertensive disorders of pregnancy. (Source: ClinicalTrials.gov)
PRECEDE - Azithromycin Prophylaxis for PRElabor CEsarean DElivery Trial
Infections are a leading cause of maternal mortality, especially due to surgical site infections and other wound complications.
PRECEDE is a randomized control trial of the administration of IV azithromycin versus a placebo to women with scheduled, non-laboring cesarean deliveries. Both groups also receive the standard of care preoperative antibiotics (excluding azithromycin).
A previous trial called C/SOAP (Cesarean Section Optimal Antibiotic Prophylaxis) looked at azithromycin versus placebo for women who were laboring or had premature rupture of membranes and found a decrease in infections surrounding cesarean deliveries for those receiving azithromycin compared to placebo. PRECEDE addresses whether that same benefit, a reduction in the risk of post-operative infection, occurs in women who are not laboring and do not have ruptured membranes but who have a cesarean delivery.
(Source: ClinicalTrials.gov)
ADEPT - Aspirin Dose Escalation for the Prevention of recurrent preterm delivery Trial
Aspirin is known to reduce clot risk and inflammation. Based on a number of robust studies, the U.S. Preventative Task Force recommends aspirin in pregnant women with risk factors for developing preeclampsia in order to reduce that risk.
The Aspirin Supplementation for Pregnancy Indicated Risk Reduction In Nulliparas (ASPIRIN) study compared the administration of 81 milligrams of aspirin versus a placebo to evaluate the impact on the incidence of preterm birth. In that study, researchers found a reduction in hypertensive disorders and other pregnancy complications including preterm birth.
ADEPT is a randomized control trial evaluating different doses of aspirin, either 81 or 162 milligrams, to women who have a history of prior preterm birth, or who have had prior ischemic placental disease (including small for gestational age, preeclampsia, placental abruption), or stillbirth.
The trial includes 1,800 individuals with a history of prior preterm birth at less than 35 weeks gestation or with prior ischemic placental disease who are randomized to receive either 162 mg aspirin or 81 mg aspirin daily. The primary study objective is to assess the effect on recurrent preterm delivery or fetal death in women with a history of spontaneous preterm delivery (sPTB), ischemic placental disease (IPD), or stillbirth using daily 162 mg of aspirin compared to 81 mg aspirin. (Source: ClinicalTrials.gov)
Completed MFMU Studies
A Trial of Pessary and Progesterone for Preterm Prevention in Twin Gestation With a Short Cervix (PROSPECT)
This protocol outlines a randomized trial of 630 women evaluating the use of micronized vaginal progesterone or pessary versus control (placebo) to prevent early preterm birth in women carrying twins and with a cervical length of less than 30 millimeters.
Multiple gestation increases the risk of preterm delivery. Babies born preterm have increased rates of neonatal mortality and long-term neurodevelopmental morbidities. Short cervical length is known to be an important risk factor for spontaneous preterm birth and to occur more frequently in women with a twin gestation. Although there is no evidence that progesterone reduces the risk of preterm birth in multifetal gestation, there is evidence that progesterone reduces the risk of prematurity in singleton gestations complicated with a short cervix. The Arabin pessary has also been shown to reduce the risk of preterm birth among singletons with a short cervix, and in a secondary subgroup analysis of a recent study of the use of pessary in multiple gestations, women with a cervical length < 25th percentile had a significantly reduced risk of the primary composite neonatal adverse outcome. Secondary analysis of studies of vaginal progesterone in multiple gestation with a short cervix also suggest a possible beneficial effect on preterm delivery. (Source: ClinicalTrials.gov)
