NCT01322529

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,038

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2010

Longer than P75 for all trials

Geographic Reach
1 country

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2011

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 24, 2011

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

January 12, 2016

Status Verified

January 1, 2016

Enrollment Period

4.7 years

First QC Date

March 10, 2011

Last Update Submit

January 11, 2016

Conditions

PregnancyPregnancy Complications

Keywords

nulliparitypregnant womenpregnancy outcomespregnancy complications

Outcome Measures

Primary Outcomes (1)

  • Adverse pregnancy outcome

    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 Outcomes (4)

  • Preterm birth

    42 weeks project estimated gestational age or less

  • Spontaneous preterm birth

    42 weeks project estimated gestational age or less

  • Indicated preterm birth

    42 weeks project estimated gestational age or less

  • Spontaneous pregnancy loss less than 20 weeks

    42 weeks project estimated gestational age or less

Eligibility Criteria

Age13 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Fountain Valley Regional Hospital and Medical Center- UCI MFM private practice

Fountain Valley, California, 92708, United States

Location

Long Beach Memorial Medical Center, Women's and Children's Hospital - Women's Perinatal Group, OB Clinic

Long Beach, California, 90801, United States

Location

University of California, Irvine, Medical Center - Prenatal care clinics and private practice

Orange, California, 92868, United States

Location

Christiana Care Health Systems

Newark, Delaware, 19718, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Indiana University School of Medicine OB/GYN

Indianapolis, Indiana, 46202, United States

Location

Columbia University Medical Center- Department of Obstetrics and Gynecology Division of Maternal Fetal Medicine

New York, New York, 10032, United States

Location

Case Western Reserve University, MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

West Penn Allegheny Health System

Pittsburgh, Pennsylvania, 15122, United States

Location

Magee Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

McKay Dee Hospital

Ogden, Utah, 84403, United States

Location

Utah Valley Regional Medical Center

Provo, Utah, 84604, United States

Location

University of Utah

Salt Lake City, Utah, 84106, United States

Location

Intermountain Medical Center

Salt Lake City, Utah, 84107, United States

Location

LDS Hospital

Salt Lake City, Utah, 84143, United States

Location

Related Publications (13)

  • 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.

    PMID: 25648779BACKGROUND

  • 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.

    PMID: 25746730BACKGROUND

  • Haas DM, Moss K, Faysal H, Yee LM, Silver RM, Grobman WA. First trimester urine glyphosate concentrations and gestational diabetes in nulliparas: a nested case-control study. Environ Health. 2025 Oct 7;24(1):71. doi: 10.1186/s12940-025-01183-6.

    PMID: 41057879DERIVED

  • Venkatesh KK, Yee LM, Johnson J, Wu J, McNeil B, Mercer B, Simhan H, Reddy UM, Silver RM, Parry S, Saade G, Chung J, Wapner R, Lynch CD, Grobman WA. Neighborhood Socioeconomic Disadvantage and Abnormal Birth Weight. Obstet Gynecol. 2023 Nov 1;142(5):1199-1207. doi: 10.1097/AOG.0000000000005384. Epub 2023 Sep 28.

    PMID: 37769319DERIVED

  • 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.

    PMID: 36138368DERIVED

  • 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.

    PMID: 35283347DERIVED

  • 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.

    PMID: 34582307DERIVED

  • 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.

    PMID: 34280383DERIVED

  • 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.

    PMID: 33345934DERIVED

  • 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.

    PMID: 32459419DERIVED

  • 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.

    PMID: 31923068DERIVED

  • 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.

    PMID: 29630018DERIVED

  • 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.

    PMID: 27632776DERIVED

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.

MeSH Terms

Conditions

Pregnancy Complications

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • George Saade, M.D.

    University of Texas

    STUDY CHAIR

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2011

First Posted

March 24, 2011

Study Start

September 1, 2010

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

January 12, 2016

Record last verified: 2016-01

Locations

US(17)