CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 10,038 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT01322529
NCT01322529N/ACompleted

Preterm Birth in Nulliparous Women: An Understudied Population at Great Risk

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)·observational·Posted Mar 24, 2011·Updated Jan 12, 2016

In Brief

An observational study for Pregnancy and Pregnancy Complications. Completed, enrolled 10,038 participants across 17 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 24, 2011
Enrollment StartSep 1, 2010
Primary CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 15.3 years ago