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Am J Obstet Gynecol. 2015 Apr;212(4):539.e1-539.e24. doi: 10.1016/j.ajog.2015.01.019. Epub 2015 Jan 31.

A description of the methods of the Nulliparous Pregnancy Outcomes Study: monitoring mothers-to-be (nuMoM2b).

Author information

1
Department of Obstetrics and Gynecology, Indiana University School of Medicine, Indianapolis, IN. Electronic address: dahaas@iupui.edu.
2
RTI International, Research Triangle Park, NC.
3
Department of Obstetrics and Gynecology, University of California, Irvine, School of Medicine, Irvine, CA.
4
Department of Obstetrics and Gynecology, University of Pennsylvania School of Medicine, Philadelphia, PA.
5
Feinberg School of Medicine, Northwestern University, Evanston, IL.
6
Case Western Reserve University School of Medicine, Cleveland, OH.
7
Department of Obstetrics and Gynecology, University of Pittsburgh School of Medicine, Pittsburgh, PA.
8
Christiana Care Health System, Newark, DE.
9
University of Utah School of Medicine, Salt Lake City, UT.
10
Department of Psychiatry, University of California, Irvine, School of Medicine, Irvine, CA.
11
The Ohio State University College of Medicine, Columbus, OH.
12
College of Physicians and Surgeons, Columbia University, New York, NY.
13
Department of Medical and Molecular Genetics, Indiana University School of Medicine, Indianapolis, IN.
14
University of Texas Medical Branch, Galveston, TX.
15
Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.

Abstract

OBJECTIVE:

The primary aim of the "Nulliparous Pregnancy Outcomes Study: monitoring mothers-to-be" is to determine maternal characteristics, which include genetic, physiologic response to pregnancy, and environmental factors that predict adverse pregnancy outcomes.

STUDY DESIGN:

Nulliparous women in the first trimester of pregnancy were recruited into an observational cohort study. Participants were seen at 3 study visits during pregnancy and again at delivery. We collected data from in-clinic interviews, take-home surveys, clinical measurements, ultrasound studies, and chart abstractions. Maternal biospecimens (serum, plasma, urine, cervicovaginal fluid) at antepartum study visits and delivery specimens (placenta, umbilical cord, cord blood) were collected, processed, and stored. The primary outcome of the study was defined as pregnancy ending at <37+0 weeks' gestation. Key study hypotheses involve adverse pregnancy outcomes of spontaneous preterm birth, preeclampsia, and fetal growth restriction.

RESULTS:

We recruited 10,037 women to the study. Basic characteristics of the cohort at screening are reported.

CONCLUSION:

The "Nulliparous Pregnancy Outcomes Study: monitoring mothers-to-be" cohort study methods and procedures can help investigators when they plan future projects.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01322529.

KEYWORDS:

adverse pregnancy outcome; cohort study; methods; nulliparous; prediction; pregnancy; psychosocial

PMID:
25648779
PMCID:
PMC4387083
DOI:
10.1016/j.ajog.2015.01.019
[Indexed for MEDLINE]
Free PMC Article

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