nuMoM2b, which bega n in 2010, studies pregnant women who will be delivering for the first time (nulliparous women). This prospective cohort study evaluates the underlying, interrelated mechanisms of several common adverse pregnancy outcomes, which can be unpredictable in women who have little or no pregnancy history to help guide their treatment. This initiative addresses a critical group of at-risk women who are currently understudied and represent 40% of the 4 million births in the United States each year. The results of this study will help inform health care providers and their patients who are pregnant or considering pregnancy. They also will support future research to improve care and outcomes in this group of women. The study was initiated by the NICHD Pregnancy and Perinatology Branch (PPB) and is primarily funded by NICHD, with co-funding from the NIH Office of Research on Women’s Health. A National Heart, Lung, and Blood Institute- funded substudy of 3,600 nuMoM2b participants is examining the relationship between sleep disorders during pregnancy and adverse pregnancy outcomes (2,850 women are currently enrolled).
nuMoM2b is enrolling racially, ethnically, and geographically diverse pregnant women through eight clinical research sites and 12 subsites around the country. Ultimately, the study will have 10,000 participants; more than 9,000 women are currently enrolled. These women participate in a variety of tests to identify potential mechanisms of adverse outcomes and predictive factors for the outcomes at four points during pregnancy.
Researchers may collect additional data through ancillary studies on subsets of the enrolled women. RTI International (Research Triangle Park, NC) serve s as the study’s Data Coordinating and Analysis Center (DCAC), which manages and analyzes the data; biological specimens are stored at a central repository (Fisher BioServices, Inc.) for later analysis.
nuMoM2b studies the mechanisms and prediction of adverse outcomes in pregnancy. The primary outcomes of interest are preterm birth, preeclampsia, fetal growth restriction, and stillbirth. The study aims to:
- Determine maternal characteristics and biomarkers, including genetics, epigenetics, and physiological response to pregnancy, as well as the environmental factors that can influence or predict adverse pregnancy outcomes.
- Identify specific aspects of placental development and function that lead to adverse pregnancy outcomes.
- Characterize genetic, growth, and developmental parameters of the fetus that are associated with adverse pregnancy outcomes.
- Case Western Reserve University
- Columbia University
- Indiana University
- Northwestern University
- Magee-Women’s Hospital
- RTI International (DCAC)
- University of California, Irvine
- University of Pennsylvania
- University of Utah
In addition, 12 subsites are participating in nuMoM2b.
NICHD Contacts: Uma Reddy and Marian Willinger