Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Office of Research on Women's Health (ORWH)
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT01322529
First received: March 10, 2011
Last updated: January 11, 2016
Last verified: January 2016
  Purpose
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.

Condition
Pregnancy
Pregnancy Complications

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Preterm Birth in Nulliparous Women: An Understudied Population at Great Risk

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Adverse pregnancy outcome [ Time Frame: 42 weeks project estimated gestational age or less ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Preterm birth [ Time Frame: 42 weeks project estimated gestational age or less ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
Blood serum, blood plasma, maternal deoxyribonucleic acid (DNA), urine supernatant, urine cell pellet, cervico-vaginal fluid, bacterial vaginosis (BV) slide, cord blood (fetal DNA), cord blood serum, placenta, fetal membranes, umbilical cord segment, placenta and umbilical cord, chorionic villi and maternal decidua from clinical chorionic villus sampling (CVS), amniotic fluid supernatant and cell pellet from clinical amniocentesis.

Enrollment: 10038
Study Start Date: September 2010
Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   13 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01322529

Locations
United States, California
Fountain Valley Regional Hospital and Medical Center- UCI MFM private practice
Fountain Valley, California, United States, 92708
Long Beach Memorial Medical Center, Women's and Children's Hospital - Women's Perinatal Group, OB Clinic
Long Beach, California, United States, 90801
University of California, Irvine, Medical Center - Prenatal care clinics and private practice
Orange, California, United States, 92868
United States, Delaware
Christiana Care Health Systems
Newark, Delaware, United States, 19718
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Indiana
Indiana University School of Medicine OB/GYN
Indianapolis, Indiana, United States, 46202
United States, New York
Columbia University Medical Center- Department of Obstetrics and Gynecology Division of Maternal Fetal Medicine
New York, New York, United States, 10032
United States, Ohio
Case Western Reserve University, MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
West Penn Allegheny Health System
Pittsburgh, Pennsylvania, United States, 15122
Magee Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
United States, Utah
McKay Dee Hospital
Ogden, Utah, United States, 84403
Utah Valley Regional Medical Center
Provo, Utah, United States, 84604
University of Utah
Salt Lake City, Utah, United States, 84106
Intermountain Medical Center
Salt Lake City, Utah, United States, 84107
LDS Hospital
Salt Lake City, Utah, United States, 84143
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Heart, Lung, and Blood Institute (NHLBI)
Office of Research on Women's Health (ORWH)
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
  More Information

Publications:
Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT01322529     History of Changes
Other Study ID Numbers: NICHD-nuMoM2b-001  1U10HD063036-01  1U10HD063072-01  1U10HD063047-01  1U10HD063037-01  1U10HD063041-01  1U10HD063020-01  1U10HD063046-01  1U10HD063048-01  1U10HD063053-01 
Study First Received: March 10, 2011
Last Updated: January 11, 2016
Health Authority: United States: Federal Government
Individual Participant Data  
Plan to Share IPD: Undecided
Plan Description: Date will be made available to authorized researchers in the future through a yet to be determined government repository.

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
nulliparity
pregnant women
pregnancy outcomes
pregnancy complications

Additional relevant MeSH terms:
Pregnancy Complications

ClinicalTrials.gov processed this record on December 02, 2016