nuMoM2b Substudy Protocol Deviations [A33] Dataset in Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-be

Data from Substudy Protocol Deviations [A33] form completed any time a deviation from one or more substudy protocols occurred that concerned the participant, potential participant, or her baby (e.g., failure to obtain consent, breach of confidentiality)
Study Description
NuMoM2b studied underlying, interrelated, mechanisms of adverse pregnancy outcomes (e.g., preterm birth, preeclampsia, fetal growth restriction) in pregnant women with no previous pregnancy lasting 20 weeks-0 days or more estimated gestational age (nulliparas). The network included 8 clinical sites, subsites, NICHD, and a data center. Women enrolled early in pregnancy and were followed through delivery, with study visits at 6 weeks-0 days to 13 weeks-6 days, 16 weeks-0 days to 21 weeks-6 days, 22 weeks-0 days to 29 weeks-6 days gestation, and delivery. Data collected through interviews, self-administered questionnaires, clinical measurements, ultrasounds, and medical records review included demographic, psychosocial, dietary, physiologic, health, and pregnancy outcome information. Subsets of participants enrolled in sleep disordered breathing, sleep patterns and quality, and fetal adrenal gland substudies. Pregnant women with no previous pregnancy lasting =20 weeks estimated gestational age (nulliparas); although 10,038 women enrolled in the study, during consent, only 9,289 of these women agreed to release their data into shared databases maintained by NIH