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PregnancynuMoM2bNCT01322529

Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-be

An observational study of Pregnancy and Pregnancy Complications, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 17 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 13 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnancy, Pregnancy Complications
How many people
10,038 participants
Where
17 sitesUnited States
Study dates
Sep 2010to May 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 years and older
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

United States17 sites

  • Northwestern University

    Chicago, Illinois, 60611

  • Case Western Reserve University, MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • The Ohio State University Medical Center

    Columbus, Ohio, 43210

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

    Fountain Valley, California, 92708

  • Indiana University School of Medicine OB/GYN

    Indianapolis, Indiana, 46202

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

    Long Beach, California, 90801

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

    New York, New York, 10032

  • Christiana Care Health Systems

    Newark, Delaware, 19718

  • McKay Dee Hospital

    Ogden, Utah, 84403

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

    Orange, California, 92868

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • West Penn Allegheny Health System

    Pittsburgh, Pennsylvania, 15122

  • Magee Womens Hospital

    Pittsburgh, Pennsylvania, 15213

  • Utah Valley Regional Medical Center

    Provo, Utah, 84604

  • University of Utah

    Salt Lake City, Utah, 84106

  • Intermountain Medical Center

    Salt Lake City, Utah, 84107

  • LDS Hospital

    Salt Lake City, Utah, 84143

Other trials in United States

About this study

Official title: 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.

Read the 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.

Keywords
nulliparity, pregnant women, pregnancy outcomes, pregnancy complications
Medical subject headings
Pregnancy Complications

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 42 weeks project estimated gestational age or less

Secondary outcomes (4)

  1. Preterm birth

    Delivery of a liveborn or stillborn infant for any cause between 20 weeks 0 days and 36 weeks 6 days project estimated gestational age.

    Measured: 42 weeks project estimated gestational age or less

  2. Spontaneous preterm birth

    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.

    Measured: 42 weeks project estimated gestational age or less

  3. Indicated preterm birth

    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.

    Measured: 42 weeks project estimated gestational age or less

  4. Spontaneous pregnancy loss less than 20 weeks

    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.

    Measured: 42 weeks project estimated gestational age or less

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2011 (estimated)
  2. Study startSep 2010
  3. Primary completionMay 2015
  4. Study completionMay 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
10,038 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01322529
Sponsor's protocol ID
NICHD-nuMoM2b-001
Other IDs
1U10HD063036-01, 1U10HD063072-01, 1U10HD063047-01, 1U10HD063037-01, 1U10HD063041-01, 1U10HD063020-01, 1U10HD063046-01, 1U10HD063048-01
Acronym
nuMoM2b
Status last verified
Jan 2016
First submitted
10 Mar 2011
Last updated
12 Jan 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided: Date will be made available to authorized researchers in the future through a yet to be determined government repository.

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.

    PubMed 25648779

  • 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.

    PubMed 25746730

  • Mahdasian-Miller A, Pena A, Haas D, Feghali M, Yee L, Wilder J, Blue N, Durnwald C, Steller J, Scifres CM. The Association Between Glucose Intolerance and Longitudinal Fetal Growth in Nulliparas. O G Open. 2026 Oct 27;3(5):e213. doi: 10.1097/og9.0000000000000213. eCollection 2026 Oct.

    PubMed 42948549

  • 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.

    PubMed 41057879

  • 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.

    PubMed 37769319

  • Post RJ, Chang J, Ziogas A, Crosland BA, Silver RM, Haas DM, Grobman WA, Saade GR, Reddy UM, Simhan H, Chung JH. Risk factors and perinatal outcomes for persistent placenta previa in nulliparas. Am J Obstet Gynecol MFM. 2023 Oct;5(10):101136. doi: 10.1016/j.ajogmf.2023.101136. Epub 2023 Aug 18.

    PubMed 37598887

  • 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.

    PubMed 36138368

  • 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.

    PubMed 35283347

  • 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.

    PubMed 34582307

  • 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.

    PubMed 34280383

  • 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.

    PubMed 33345934

  • 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.

    PubMed 32459419

  • 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.

    PubMed 31923068

  • 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.

    PubMed 29630018

  • 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.

    PubMed 27632776

Questions about this trial

What is this clinical trial studying?

An observational study of Pregnancy and Pregnancy Complications, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 17 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse pregnancy outcome (time frame: 42 weeks project estimated gestational age or less). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01322529, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2016; AzTrials last refreshed its copy on 8 Nov 2026.

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