Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-be (nuMoM2b)

Preterm Birth in Nulliparous Women: An Understudied Population at Great Risk

Forty percent of pregnant women in the United States are women who have never given birth. As a group, they sometimes have complications with their pregnancy, but there is no information from a previous pregnancy to identify who might have a problem. Very little research has been done with this group. The Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-be (nuMoM2b) is collecting data from a diverse population of about 10,000 women who are having their first baby and are carrying only one baby. The women are enrolled early in pregnancy and undergo research assessments four times during their pregnancies. Data are collected through interviews, self-completed data forms, clinical measurements, ultrasound, and collection and storage of blood samples, urine samples, and fluid from the vagina and cervix. Some information comes from medical records. A subset of women may be asked to participate in substudies collecting information on sleep breathing, sleep patterns and quality, or other areas possibly related to birth outcomes. The goal of the research is to find ways to identify women in this group who might develop a problem with their pregnancy and use this information to improve the health of pregnant women and their babies in the future. The study is focusing on pregnancy problems like high blood pressure, babies that are born much too early and very small babies.

Study Overview

Status

Completed

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

Observational

Enrollment (Actual)

10038

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Fountain Valley, California, United States, 92708
        • Fountain Valley Regional Hospital and Medical Center- UCI MFM private practice
      • Long Beach, California, United States, 90801
        • Long Beach Memorial Medical Center, Women's and Children's Hospital - Women's Perinatal Group, OB Clinic
      • Orange, California, United States, 92868
        • University of California, Irvine, Medical Center - Prenatal care clinics and private practice
    • Delaware
      • Newark, Delaware, United States, 19718
        • Christiana Care Health Systems
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University School of Medicine OB/GYN
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center- Department of Obstetrics and Gynecology Division of Maternal Fetal Medicine
    • Ohio
      • Cleveland, Ohio, United States, 44109
        • Case Western Reserve University, MetroHealth Medical Center
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Magee Womens Hospital
      • Pittsburgh, Pennsylvania, United States, 15122
        • West Penn Allegheny Health System
    • Utah
      • Ogden, Utah, United States, 84403
        • Mckay Dee Hospital
      • Provo, Utah, United States, 84604
        • Utah Valley Regional Medical Center
      • Salt Lake City, Utah, United States, 84143
        • LDS Hospital
      • Salt Lake City, Utah, United States, 84107
        • Intermountain Medical Center
      • Salt Lake City, Utah, United States, 84106
        • University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

The study population consists of a racially/ethnically/geographically diverse population of 10,038 nulliparous pregnant women with singleton gestations recruited through 8 participating clinical sites and their subsites.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
42 weeks project estimated gestational age or less

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
42 weeks project estimated gestational age or less
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.
42 weeks project estimated gestational age or less
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.
42 weeks project estimated gestational age or less
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.
42 weeks project estimated gestational age or less

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (ACTUAL)

May 1, 2015

Study Completion (ACTUAL)

May 1, 2015

Study Registration Dates

First Submitted

March 10, 2011

First Submitted That Met QC Criteria

March 23, 2011

First Posted (ESTIMATE)

March 24, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

January 12, 2016

Last Update Submitted That Met QC Criteria

January 11, 2016

Last Verified

January 1, 2016

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)?

UNDECIDED

IPD Plan Description

Date will be made available to authorized researchers in the future through a yet to be determined government repository.

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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