Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-be (nuMoM2b)
|ClinicalTrials.gov Identifier: NCT01322529|
Recruitment Status : Completed
First Posted : March 24, 2011
Last Update Posted : January 12, 2016
|Condition or disease|
|Pregnancy Pregnancy Complications|
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) established the Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-be (nuMoM2b) to study women for whom the current pregnancy will lead to their first delivery (nulliparas). About 40% of pregnant women in the United States are nulliparas. Because little or no information from previous pregnancy outcomes is available to guide assignment of risk or mitigating interventions, adverse pregnancy outcomes in nulliparas are especially unpredictable. The underlying mechanisms of adverse pregnancy outcomes such as preterm birth, preeclampsia, fetal growth restriction and stillbirth are interrelated and therefore will be evaluated as part of this study. The information gained will benefit women who are pregnant or who are considering pregnancy and their physicians. In addition, the knowledge will support future research aimed at improving care and health outcomes for a critical group of at-risk women who are currently understudied.
The study is a prospective cohort study of a racially/ethnically/geographically diverse population of 10,038 nulliparous women with singleton gestations. The women undergo intensive research assessments during the course of their pregnancies to study the mechanisms for and prediction of adverse pregnancy outcomes (APOs) in women in their first pregnancy. The APOs of primary interest are preterm birth, preeclampsia and fetal growth restriction.
The goals of the study are to 1) determine maternal characteristics, including genetics, epigenetics, and physiological response to pregnancy as well as environmental factors that influence and/or predict adverse pregnancy outcome; 2) identify specific aspects of placental development and function that lead to adverse pregnancy outcome; and 3) characterize genetic, growth, and developmental parameters of the fetus that are associated with adverse pregnancy outcome.
Eight academic medical centers or sites had primary responsibility for enrollment and follow-up of study participants. Several of these sites collected data through additional academic research centers or nearby hospitals (subsites). A Data Coordinating and Analysis Center (DCAC) provided input to the protocol, manages the data, and analyzes the data. Investigators from these institutions have established a partnership with NICHD staff to develop and implement the study protocol and ancillary studies that acquire and analyze data to identify biomarkers and understand the mechanism and prediction of preterm birth and other adverse pregnancy outcomes.
Nulliparous women with an in utero singleton gestation between 6 weeks 0 days and 13 weeks 6 days of pregnancy were recruited through the eight clinical sites and their subsites. Mechanisms were created in the various prenatal clinics associated with the sites to identify eligible nulliparous women with singleton pregnancies. Once enrolled, a participant was followed for the duration of her pregnancy by research staff at the clinical site. Study visits were scheduled at four times during the pregnancy: 6 weeks 0 days through 13 weeks 6 days estimated gestational age (EGA), 16 weeks 0 days through 21 weeks 6 days EGA, 22 weeks 0 days through 29 weeks 6 days EGA, and at the time of delivery. Data were collected through personal interview, self-administered questionnaires, clinical measurement, chart abstraction, and collection of biological specimens (blood, urine, cervico-vaginal fluid). Additional data (i.e., sleep breathing assessments, actigraphy, fetal adrenal gland measurements) were collected through ancillary research studies on subsets of the enrolled women. The set-ups for screening, enrollment and follow-up of participants varied by clinical site and subsite. However, in each setting, the clinical site staffs included study investigators, research nurses, research assistants and sonographers. Clinical site staffs were trained to interview participants, collect and process samples, conduct various research tests, and input data. Data are managed at the DCAC. Specimens are stored at the NICHD specimen repository for later analysis.
|Study Type :||Observational|
|Actual Enrollment :||10038 participants|
|Official Title:||Preterm Birth in Nulliparous Women: An Understudied Population at Great Risk|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||May 2015|
- Adverse pregnancy outcome [ Time Frame: 42 weeks project estimated gestational age or less ]Delivery of a live born or stillborn infant due to any cause before 37 weeks 0 days project estimated gestational age, after the subject has been enrolled in the study.
- Preterm birth [ Time Frame: 42 weeks project estimated gestational age or less ]Delivery of a liveborn or stillborn infant for any cause between 20 weeks 0 days and 36 weeks 6 days project estimated gestational age.
- Spontaneous preterm birth [ Time Frame: 42 weeks project estimated gestational age or less ]Delivery occurring subsequent to spontaneous onset of preterm labor OR preterm Premature Rupture of the Membranes (preterm PROM) OR fetal membrane prolapse, regardless of subsequent labor augmentation or cesarean delivery.
- Indicated preterm birth [ Time Frame: 42 weeks project estimated gestational age or less ]Delivery following induction or cesarean delivery at less than 37 weeks 0 days gestation for one or more conditions that the woman's caregiver determines to threaten the health/life of the mother or fetus. The primary diagnoses associated with indicated preterm birth are categorized as follows: pregnancy associated hypertension, fetal growth restriction, abruptio placentae, placenta previa, chorioamnionitis, abnormal fetal testing, congenital fetal anomaly(ies), maternal medical condition, other, not documented.
- Spontaneous pregnancy loss less than 20 weeks [ Time Frame: 42 weeks project estimated gestational age or less ]Fetal death leading to vaginal delivery or dilatation and curettage/evacuation, or spontaneous expulsion of a liveborn fetus due to any cause before 20 weeks 0 days project EGA.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01322529
|Study Chair:||George Saade, M.D.||University of Texas|
|Principal Investigator:||Brian M Mercer, M.D.||Case Western Reserve University|
|Principal Investigator:||Ronald Wapner, M.D.||Columbia University|
|Principal Investigator:||David M Haas, M.D., M.S.||Indiana University|
|Principal Investigator:||Hyagriv N Simhan, MD, MSCR||Magee-Women's Hospital - University of Pittsburgh|
|Principal Investigator:||William Grobman, M.D., M.B.A.||Northwestern University|
|Principal Investigator:||Deborah A Wing, M.D.||University of California, Irvine|
|Principal Investigator:||Samuel Parry, M.D.||University of Pennsylvania|
|Principal Investigator:||Robert M Silver, M.D.||University of Utah|
|Principal Investigator:||Cora (Corette) B Parker, MSPH, DrPH||RTI International|