Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-be

Completed

Conditions studied: Pregnancy, Pregnancy Complications

In brief

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.

Key facts

Study ID

NCT01322529

Run by

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

People needed

10038

Starts

2010-09-01

Expected to finish

2015-05-01

Last updated by the study team

2016-01-12

Who can join

Age: 13 and older. Sex: female. Healthy volunteers: accepted.

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.

Where it is running

• Fountain Valley Regional Hospital and Medical Center- UCI MFM private practice — Fountain Valley, California, United States
• Long Beach Memorial Medical Center, Women's and Children's Hospital - Women's Perinatal Group, OB Clinic — Long Beach, California, United States
• University of California, Irvine, Medical Center - Prenatal care clinics and private practice — Orange, California, United States
• Christiana Care Health Systems — Newark, Delaware, United States
• Northwestern University — Chicago, Illinois, United States
• Indiana University School of Medicine OB/GYN — Indianapolis, Indiana, United States
• Columbia University Medical Center- Department of Obstetrics and Gynecology Division of Maternal Fetal Medicine — New York, New York, United States
• Case Western Reserve University, MetroHealth Medical Center — Cleveland, Ohio, United States
• The Ohio State University Medical Center — Columbus, Ohio, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• West Penn Allegheny Health System — Pittsburgh, Pennsylvania, United States
• Magee Womens Hospital — Pittsburgh, Pennsylvania, United States
• McKay Dee Hospital — Ogden, Utah, United States
• Utah Valley Regional Medical Center — Provo, Utah, United States
• University of Utah — Salt Lake City, Utah, United States
• Intermountain Medical Center — Salt Lake City, Utah, United States
• LDS Hospital — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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