- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01322529
Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-be (nuMoM2b)
Preterm Birth in Nulliparous Women: An Understudied Population at Great Risk
Study Overview
Status
Conditions
Detailed Description
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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California
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Fountain Valley, California, United States, 92708
- Fountain Valley Regional Hospital and Medical Center- UCI MFM private practice
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Long Beach, California, United States, 90801
- Long Beach Memorial Medical Center, Women's and Children's Hospital - Women's Perinatal Group, OB Clinic
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Orange, California, United States, 92868
- University of California, Irvine, Medical Center - Prenatal care clinics and private practice
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Delaware
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Newark, Delaware, United States, 19718
- Christiana Care Health Systems
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern University
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Indiana
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Indianapolis, Indiana, United States, 46202
- Indiana University School of Medicine OB/GYN
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New York
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New York, New York, United States, 10032
- Columbia University Medical Center- Department of Obstetrics and Gynecology Division of Maternal Fetal Medicine
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Ohio
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Cleveland, Ohio, United States, 44109
- Case Western Reserve University, MetroHealth Medical Center
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Columbus, Ohio, United States, 43210
- The Ohio State University Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- Magee Womens Hospital
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Pittsburgh, Pennsylvania, United States, 15122
- West Penn Allegheny Health System
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Utah
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Ogden, Utah, United States, 84403
- Mckay Dee Hospital
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Provo, Utah, United States, 84604
- Utah Valley Regional Medical Center
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Salt Lake City, Utah, United States, 84143
- LDS Hospital
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Salt Lake City, Utah, United States, 84107
- Intermountain Medical Center
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Salt Lake City, Utah, United States, 84106
- University of Utah
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Nullipara - Pregnant women with no prior pregnancy lasting 20 weeks 0 days or greater.
- Viable singleton gestation - a single living fetus with fetal cardiac activity at the most recent ultrasound before enrollment
- Between 6 weeks 0 days and 13 weeks 6 days project estimated gestational age (EGA) at first study visit.
- Intend to deliver at a participating hospital.
Exclusion Criteria:
- Participant age <13 years.
- History of 3 or more spontaneous abortions.
- Fetal malformation evident at or before enrollment that is likely lethal (e.g., anencephaly, hydrops, diffuse subcutaneous edema or cystic hygroma, ectopic cordis, encephalocele).
- Known fetal aneuploidy (based on chorionic villus sampling).
- Surrogate pregnancy (donor oocyte pregnancy).
- Multifetal reduction.
- Participating in an intervention study that is anticipated to influence maternal or fetal morbidities/mortality unless it is determined before enrollment that the study code will be made available.
- Woman previously enrolled in this study, including those consented but delivered before 20 weeks 0 days gestation.
- Planned pregnancy termination.
- Unable to provide informed consent.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Adverse pregnancy outcome
Time Frame: 42 weeks project estimated gestational age or less
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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.
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42 weeks project estimated gestational age or less
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Preterm birth
Time Frame: 42 weeks project estimated gestational age or less
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Delivery of a liveborn or stillborn infant for any cause between 20 weeks 0 days and 36 weeks 6 days project estimated gestational age.
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42 weeks project estimated gestational age or less
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Spontaneous preterm birth
Time Frame: 42 weeks project estimated gestational age or less
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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.
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42 weeks project estimated gestational age or less
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Indicated preterm birth
Time Frame: 42 weeks project estimated gestational age or less
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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.
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42 weeks project estimated gestational age or less
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Spontaneous pregnancy loss less than 20 weeks
Time Frame: 42 weeks project estimated gestational age or less
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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.
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42 weeks project estimated gestational age or less
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Collaborators and Investigators
Collaborators
Investigators
- 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
Publications and helpful links
General Publications
- Haas DM, Parker CB, Wing DA, Parry S, Grobman WA, Mercer BM, Simhan HN, Hoffman MK, Silver RM, Wadhwa P, Iams JD, Koch MA, Caritis SN, Wapner RJ, Esplin MS, Elovitz MA, Foroud T, Peaceman AM, Saade GR, Willinger M, Reddy UM; NuMoM2b study. A description of the methods of the Nulliparous Pregnancy Outcomes Study: monitoring mothers-to-be (nuMoM2b). Am J Obstet Gynecol. 2015 Apr;212(4):539.e1-539.e24. doi: 10.1016/j.ajog.2015.01.019. Epub 2015 Jan 31.
- Facco FL, Parker CB, Reddy UM, Silver RM, Louis JM, Basner RC, Chung JH, Schubert FP, Pien GW, Redline S, Mobley DR, Koch MA, Simhan HN, Nhan-Chang CL, Parry S, Grobman WA, Haas DM, Wing DA, Mercer BM, Saade GR, Zee PC. NuMoM2b Sleep-Disordered Breathing study: objectives and methods. Am J Obstet Gynecol. 2015 Apr;212(4):542.e1-127. doi: 10.1016/j.ajog.2015.01.021. Epub 2015 Mar 4.
- Haas DM, Yang Z, Parker CB, Chung J, Parry S, Grobman WA, Mercer BM, Simhan HN, Silver RM, Wapner RJ, Saade GR, Greenland P, Merz NB, Reddy UM, Pemberton VL; nuMoM2b study and the nuMoM2b Heart Health Study. Factors associated with duration of breastfeeding in women giving birth for the first time. BMC Pregnancy Childbirth. 2022 Sep 22;22(1):722. doi: 10.1186/s12884-022-05038-7.
- Beck C, Allshouse A, Silver RM, Grobman WA, Simhan H, Haas D, Reddy UM, Blue NR. High early pregnancy body mass index is associated with alterations in first- and second-trimester angiogenic biomarkers. Am J Obstet Gynecol MFM. 2022 May;4(3):100614. doi: 10.1016/j.ajogmf.2022.100614. Epub 2022 Mar 10.
- Blue NR, Allshouse AA, Grobman WA, Day RC, Haas DM, Simhan HN, Parry S, Saade GR, Silver RM. Developing a predictive model for perinatal morbidity among small for gestational age infants. J Matern Fetal Neonatal Med. 2022 Dec;35(25):8462-8471. doi: 10.1080/14767058.2021.1980533. Epub 2021 Sep 28.
- Miller ES, Saade GR, Simhan HN, Monk C, Haas DM, Silver RM, Mercer BM, Parry S, Wing DA, Reddy UM, Grobman WA. Trajectories of antenatal depression and adverse pregnancy outcomes. Am J Obstet Gynecol. 2022 Jan;226(1):108.e1-108.e9. doi: 10.1016/j.ajog.2021.07.007. Epub 2021 Jul 17.
- Dude AM, Plunkett B, Grobman W, Scifres CM, Mercer BM, Parry S, Silver RM, Wapner R, Wing DA, Saade G, Reddy U, Iams J, Simhan H, Kominiarek MA. The association between personal weight gain goals, provider recommendations, and appropriate gestational weight gain. Am J Obstet Gynecol MFM. 2020 Nov;2(4):100231. doi: 10.1016/j.ajogmf.2020.100231. Epub 2020 Sep 22.
- Haas DM, Mahnke B, Yang Z, Guise D, Daggy J, Simhan HN, Silver RM, Grobman WA, Wapner RJ, Makhoul J, Parry S, Mercer BM, Saade GR. Profile of Reported Alcohol, Tobacco, and Recreational Drug Use in Nulliparous Women. Obstet Gynecol. 2020 Jun;135(6):1281-1288. doi: 10.1097/AOG.0000000000003826.
- Premkumar A, Debbink MP, Silver RM, Haas DM, Simhan HN, Wing DA, Parry S, Mercer BM, Iams J, Reddy UM, Saade G, Grobman WA. Association of Acculturation With Adverse Pregnancy Outcomes. Obstet Gynecol. 2020 Feb;135(2):301-309. doi: 10.1097/AOG.0000000000003659.
- Haas DM, Marsh DJ, Dang DT, Parker CB, Wing DA, Simhan HN, Grobman WA, Mercer BM, Silver RM, Hoffman MK, Parry S, Iams JD, Caritis SN, Wapner RJ, Esplin MS, Elovitz MA, Peaceman AM, Chung J, Saade GR, Reddy UM. Prescription and Other Medication Use in Pregnancy. Obstet Gynecol. 2018 May;131(5):789-798. doi: 10.1097/AOG.0000000000002579.
- Michaliszyn SF, Sjaarda LA, Scifres C, Simhan H, Arslanian SA. Maternal excess gestational weight gain and infant waist circumference: a 2-y observational study. Pediatr Res. 2017 Jan;81(1-1):63-67. doi: 10.1038/pr.2016.174. Epub 2016 Sep 15.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NICHD-nuMoM2b-001
- 1U10HD063036-01 (NIH)
- 1U10HD063072-01 (NIH)
- 1U10HD063047-01 (NIH)
- 1U10HD063037-01 (NIH)
- 1U10HD063041-01 (NIH)
- 1U10HD063020-01 (NIH)
- 1U10HD063046-01 (NIH)
- 1U10HD063048-01 (NIH)
- 1U10HD063053-01 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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