Baylor College of Medicine & Texas Children's Clinical Center for Research in the NICHD Maternal-Fetal Medicine Units (MFMU) Network

In 1986, the NICHD established the MFMU Network to respond to the need for well-designed trials in perinatal medicine. The primary objective of the MFMU Network is to improve obstetrics care, pregnancy health, and outcomes for pregnant and lactating people and their infants by establishing and maintaining a cooperative network of academic

centers that perform multi-center clinical protocols in a rigorous manner. Our application entitled ‘Baylor College of Medicine (BCM) and Texas Children’s Clinical Center for Research in the NICHD Maternal-Fetal Medicine Units (MFMU) Network’ will meet and exceed these stated goals. In anticipation of this application, we have spent the last decade

cultivating a culture amongst our academic Maternal-Fetal Medicine (MFM) team which encourages clinical research as part and parcel to reducing maternal and neonatal morbidity and mortality. The innovation and state-of-the-science translational and clinical research infrastructure we have developed along the way will enable successful

implementation and execution of MFMU studies at our Center, and enrich the science of the Network. Specific Aim 1. Work cooperatively and collaboratively as a team of dedicated academic Maternal-Fetal Medicine (MFM) physicians and physician scientists to develop, implement, and execute MFMU Network trials. From our academic division of 38 ABOG

certified/eligible MFM physicians, we have assembled a core team of clinician scientists with prior significant MFMU and other clinical trials experience, demonstrated academic productivity, and a breadth of clinical and translational capabilities. Drs. Kjersti Aagaard (PI) and Carey Eppes (Alternate PI) will continue their decade-long journey as

dedicated “MFM clinical team science leaders”. Working hand-in-hand with existing dedicated MFM research staff, this team is built with the firm promise of Departmental and Institutional Commitment (dedicated time & financial resources) and is dedicated to generating the evidence necessary to inform best clinical care for all pregnant people.

Specific Aim 2. Enable the recruitment, enrollment, and long term follow up of our unique and robust population of

gravidae available for clinical trials. Our two principal MFMU clinical sites are nearly adjacent to each other in the Texas

Medical Center in Houston, and are the site of over 11,000 deliveries annually, with nearly 2/3 “high risk” and having

received the majority of their prenatal care at our MFMU clinical center sties. We will address how we will synergistically enrich the overall Network scope and impact by recruiting & retaining populations who are disproportionately affected.

Specific Aim 3. Leverage the clinical and translational research capabilities at Baylor College of Medicine/Texas Children’s MFMU Clinical Center in order to develop and expand the scientific richness of the MFMU Network. The depth and

breadth of clinical expertise, clinical trials experience, and notably cutting-edge translational research that focus on

pregnancy and lactation are unique strengths of this application. We will detail the proven capabilities of our Division members and our collaborators, and identify how our nearly unparalleled special strengths will be shared and available to bolster the innovation and advancement of the scientific goals, vision and mission of the MFMU and the NICHD.