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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01322529
Other study ID # NICHD-nuMoM2b-001
Secondary ID 1U10HD063036-011
Status Completed
Phase N/A
First received March 10, 2011
Last updated January 11, 2016
Start date September 2010
Est. completion date May 2015

Study information

Verified date January 2016
Source Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical 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. 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.


Description:

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Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


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Sponsors (3)

Lead Sponsor Collaborator
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)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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. 42 weeks project estimated gestational age or less No
Secondary 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. 42 weeks project estimated gestational age or less No
Secondary 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. 42 weeks project estimated gestational age or less No
Secondary 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. 42 weeks project estimated gestational age or less No
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