Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-be

NCT01322529 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 10038

Last updated 2016-01-12

No results posted yet for this study

Summary

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.

Conditions

  • Pregnancy
  • Pregnancy Complications

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH
  • Office of Research on Women's Health (ORWH)

    collaborator NIH
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    lead NIH

Principal Investigators

  • George Saade, M.D. · University of Texas

  • Brian M Mercer, M.D. · Case Western Reserve University

  • Ronald Wapner, M.D. · Columbia University

  • David M Haas, M.D., M.S. · Indiana University

  • Hyagriv N Simhan, MD, MSCR · Magee-Women's Hospital - University of Pittsburgh

  • William Grobman, M.D., M.B.A. · Northwestern University

  • Deborah A Wing, M.D. · University of California, Irvine

  • Samuel Parry, M.D. · University of Pennsylvania

  • Robert M Silver, M.D. · University of Utah

  • Cora (Corette) B Parker, MSPH, DrPH · RTI International

Eligibility

Min Age
13 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2015-05-31
Completion
2015-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01322529 on ClinicalTrials.gov