The clinical sites and data center participating in the NICHD Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-be (nuMoM2b) are jointly submitting applications to NHLBI for a prospective, follow-up study of the nuMoM2b cohort to examine the association betweenadverse pregnancy outcomes (APOs) and cardiovascular (CV) risk at ~2 years postpartum. In the parent study, the nuMoM2b cohort of 10,000 ethnically and geographically diverse nulliparous women is evaluated over the course of pregnancy to study the mechanisms for and prediction of APOs. Demographic, psychosocial, dietary, physiologic and outcome information are collected through maternal interviews, self-administered questionnaires, clinical measurements, ultrasounds, and medical records abstraction. Samples of maternal blood, urine, and cervico-vaginal fluid over pregnancy, and cord blood and placenta at delivery are collected and banked. Approximately 1/3 of the women participate in overnight sleep studies 2 times during pregnancy. The follow-up study materials will be finalized in September and the study conducted between October 2013 and June 2017. 6-month postpartum contacts initiated on the parent study to maintain contact will be expanded to gather information on subsequent pregnancies. Women with subsequent completed pregnancies will be queriedabout APOsand asked for a medical records release so that study staff can verify any reported APOs using strict criteria. At ~2 years after the index delivery, women who are not pregnant or within 6 months postpartum will be recruited for CV assessments. Participants with sleep studies during the index pregnancy will be recruited for an overnight sleep study. This NHLBI follow-up study leverages theextensive phenotypic information about APOs on the large nuMoM2b cohort to systematically elucidate aspects of CV risk associated with APOs and improve the health of women with a history of APOs. The Principal Investigators who successfully designed and managed nuMoM2b will lead the follow-up study and bring expertise from their sites in CV disease, obstetrics and gynecology, sleep disorders, and epidemiology. Dr. George Saade, the nuMoM2b Steering Committee chairperson, will chair the Follow-up Study Steering Committee and Dr. Phyllis Zee will chair a Sleep Subcommittee. Dr. Noel Bairey-Merz, a recognized authority on heart disease and stress, will serve as an outside consultant, contributing to the development of the final protocol and consulting on issues during the study and on the analysis and interpretation of the data.
|Effective start/end date||8/24/13 → 4/30/18|
- National Heart, Lung, and Blood Institute (U10HL119992)
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