The goals of this 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.
NuMoM2b is designed as a prospective cohort study. The planned accrual period is 12 to 15 months. The target recruitment for the study is 10,000 nulliparous women with singleton pregnancies, enrolled at 6-0/7 - 13-6/7 weeks of gestation.
After screening and eligibility has been determined, participants will be seen at 6-13 weeks gestation, 16-21 weeks gestation, 22-29 weeks gestation, and at delivery. During these visits, the following procedures may be performed: clinical measurements, interviews, questionnaires (some take-home), blood and urine sample collection, collection of cervico-vaginal fluid and ultrasound.
For women who have amniocentesis for medically-indicated reasons, or experience a pregnancy loss, additional consent may be obtained to request permission to use samples from these tests for the study.