NICHD Nulliparous Pregnancy Outcomes Study Monitoring Mothers-to-be (NuMoM2b)
|Principal Investigator: BobSilver|
|Keywords: Pregnant , First Pregnancy , First Time Moms||Department: Obstetrics And Gynecology (Dept)|
|IRB Number: 00044028||Co Investigator: Sean Esplin|
|Specialty: Maternal-Fetal Medicine|
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.
1. Nullipara - Pregnant women with no prior pregnancy lasting 20 weeks 0 days or greater based on the patient’s recollection. A recollection of a birth weight for a prior pregnancy of 12 ounces (360 grams) or greater will be considered evidence of a pregnancy lasting 20 weeks 0 days gestation or greater. Where relevant, study staff confirm gestational age of prior deliveries through a review of medical records, if available.
2. Viable singleton gestation - All participants must have an ultrasound performed prior to enrollment. Viability is defined as the presence of fetal cardiac activity at the most recent ultrasound before enrollment. Those with vaginal bleeding during pregnancy must have a documented viable intrauterine pregnancy at or after the onset of vaginal bleeding. A singleton gestation is defined as single living fetus, resulting from a singleton gestation or from a twin gestation with demise of (only) one fetus occurring at any time before enrollment.
3. Between 6 weeks 0 days and 13 weeks 6 days “project estimated gestational age” (EGA) at first visit. All participants must have a “project ultrasound” (defined as the earliest ultrasound for which written documentation of a crown-rump length measurement is available) performed prior to enrollment. This ultrasound will be used to determine the “project estimated date of delivery” (EDD) as described in Section B.5 of the main protocol and the “project estimated gestational age (EGA) over time. The project EGA must be between 6 weeks 0 days and 13 weeks 6 days at the time of the first visit.
4. Intention to deliver at a participating nuMoM2b Network hospital.
1. Participant age <13 years.
2. History of 3 or more spontaneous abortions.
3. Fetal malformation evident at or before enrollment that is likely lethal (e.g., anencephaly, hydrops, diffuse subcutaneous edema or cystic hygroma, ectopic cordis, encephalocele).
4. Known fetal aneuploidy (based on chorionic villus sampling).
5. Surrogate pregnancy (donor oocyte pregnancy).
6. Multifetal reduction.
7. 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.
8. Woman previously enrolled in the nuMoM2b study, including those consented but delivered before 20 weeks 0 days gestation.
9. Planned pregnancy termination.
10. Unable to provide informed consent.