THE MATERNAL-FETAL MEDICINE UNITS (MFMU) AND THE SAFE PASSAGE STUDY (PASS)

Maternal-Fetal Medicine Units (MFMU) Network: The MFMU Network was established in 1986 to conduct clinical studies to improve maternal, fetal and neonatal health emphasizing randomized-controlled trials. The Network goals were to reduce maternal, fetal and infant morbidity related to preterm birth, fetal growth abnormalities and maternal complications. The MFMU Network, composed of 14 clinical centers across the United States and a data coordinating center (GWU), oversaw a number of clinical trials to advance their goals. The Safe Passage Study (PASS): The Safe Passage Study was a prospective study spanning early pregnancy through the first twelve months of infant life with assessments of fetal and infant autonomic function, neurobehavioral development, maternal and infant medical risks, and detailed assessments of prenatal alcohol consumption and fetal exposure to smoking and drugs of abuse. Enrollment was completed early 2015 and 12,084 pregnant women were enrolled. Specimens include: maternal DNA from saliva, infant cord blood and Guthrie cards, placental tissue and paraffin blocks, frozen and fixed brain tissue from demises, and meconium. Under this Task Order, the Government requires repository services for human biospecimens generated in the PASS study as well as the MFMU studies. The Contractor shall provide all services as defined in the IDIQ Contract 75N94025D00002, as well as store, maintain, and disburse human biological specimens from this collection. Re-labeling and destruction of specimens shall occur as necessary at the request of NICHD personnel.