Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-be

Pregnancy Clinical Trial

— nuMoM2b  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01322529
• Other study ID #: NICHD-nuMoM2b-001
• Secondary ID: 1U10HD063036-011
• Status: Completed
• Phase: N/A
• First received: March 10, 2011
• Last updated: January 11, 2016
• Start date: September 2010
• Est. completion date: May 2015

Study information

• Verified date: January 2016
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

Description:

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) established the Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-be (nuMoM2b) to study women for whom the current pregnancy will lead to their first delivery (nulliparas). About 40% of pregnant women in the United States are nulliparas. Because little or no information from previous pregnancy outcomes is available to guide assignment of risk or mitigating interventions, adverse pregnancy outcomes in nulliparas are especially unpredictable. The underlying mechanisms of adverse pregnancy outcomes such as preterm birth, preeclampsia, fetal growth restriction and stillbirth are interrelated and therefore will be evaluated as part of this study. The information gained will benefit women who are pregnant or who are considering pregnancy and their physicians. In addition, the knowledge will support future research aimed at improving care and health outcomes for a critical group of at-risk women who are currently understudied.

The study is a prospective cohort study of a racially/ethnically/geographically diverse population of 10,038 nulliparous women with singleton gestations. The women undergo intensive research assessments during the course of their pregnancies to study the mechanisms for and prediction of adverse pregnancy outcomes (APOs) in women in their first pregnancy. The APOs of primary interest are preterm birth, preeclampsia and fetal growth restriction.

The goals of the 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.

Eight academic medical centers or sites had primary responsibility for enrollment and follow-up of study participants. Several of these sites collected data through additional academic research centers or nearby hospitals (subsites). A Data Coordinating and Analysis Center (DCAC) provided input to the protocol, manages the data, and analyzes the data. Investigators from these institutions have established a partnership with NICHD staff to develop and implement the study protocol and ancillary studies that acquire and analyze data to identify biomarkers and understand the mechanism and prediction of preterm birth and other adverse pregnancy outcomes.

Nulliparous women with an in utero singleton gestation between 6 weeks 0 days and 13 weeks 6 days of pregnancy were recruited through the eight clinical sites and their subsites. Mechanisms were created in the various prenatal clinics associated with the sites to identify eligible nulliparous women with singleton pregnancies. Once enrolled, a participant was followed for the duration of her pregnancy by research staff at the clinical site. Study visits were scheduled at four times during the pregnancy: 6 weeks 0 days through 13 weeks 6 days estimated gestational age (EGA), 16 weeks 0 days through 21 weeks 6 days EGA, 22 weeks 0 days through 29 weeks 6 days EGA, and at the time of delivery. Data were collected through personal interview, self-administered questionnaires, clinical measurement, chart abstraction, and collection of biological specimens (blood, urine, cervico-vaginal fluid). Additional data (i.e., sleep breathing assessments, actigraphy, fetal adrenal gland measurements) were collected through ancillary research studies on subsets of the enrolled women. The set-ups for screening, enrollment and follow-up of participants varied by clinical site and subsite. However, in each setting, the clinical site staffs included study investigators, research nurses, research assistants and sonographers. Clinical site staffs were trained to interview participants, collect and process samples, conduct various research tests, and input data. Data are managed at the DCAC. Specimens are stored at the NICHD specimen repository for later analysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10038
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 13 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pregnancy
• Pregnancy Complications

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	National Heart, Lung, and Blood Institute (NHLBI), Office of Research on Women's Health (ORWH)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Facco FL, Parker CB, Reddy UM, Silver RM, Louis JM, Basner RC, Chung JH, Schubert FP, Pien GW, Redline S, Mobley DR, Koch MA, Simhan HN, Nhan-Chang CL, Parry S, Grobman WA, Haas DM, Wing DA, Mercer BM, Saade GR, Zee PC. NuMoM2b Sleep-Disordered Breathing study: objectives and methods. Am J Obstet Gynecol. 2015 Apr;212(4):542.e1-127. doi: 10.1016/j.ajog.2015.01.021. Epub 2015 Mar 4. — View Citation

Haas DM, Parker CB, Wing DA, Parry S, Grobman WA, Mercer BM, Simhan HN, Hoffman MK, Silver RM, Wadhwa P, Iams JD, Koch MA, Caritis SN, Wapner RJ, Esplin MS, Elovitz MA, Foroud T, Peaceman AM, Saade GR, Willinger M, Reddy UM; NuMoM2b study. A description of the methods of the Nulliparous Pregnancy Outcomes Study: monitoring mothers-to-be (nuMoM2b). Am J Obstet Gynecol. 2015 Apr;212(4):539.e1-539.e24. doi: 10.1016/j.ajog.2015.01.019. Epub 2015 Jan 31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse pregnancy outcome	Delivery of a live born or stillborn infant due to any cause before 37 weeks 0 days project estimated gestational age, after the subject has been enrolled in the study.	42 weeks project estimated gestational age or less	No
Secondary	Preterm birth	Delivery of a liveborn or stillborn infant for any cause between 20 weeks 0 days and 36 weeks 6 days project estimated gestational age.	42 weeks project estimated gestational age or less	No
Secondary	Spontaneous preterm birth	Delivery occurring subsequent to spontaneous onset of preterm labor OR preterm Premature Rupture of the Membranes (preterm PROM) OR fetal membrane prolapse, regardless of subsequent labor augmentation or cesarean delivery.	42 weeks project estimated gestational age or less	No
Secondary	Indicated preterm birth	Delivery following induction or cesarean delivery at less than 37 weeks 0 days gestation for one or more conditions that the woman's caregiver determines to threaten the health/life of the mother or fetus. The primary diagnoses associated with indicated preterm birth are categorized as follows: pregnancy associated hypertension, fetal growth restriction, abruptio placentae, placenta previa, chorioamnionitis, abnormal fetal testing, congenital fetal anomaly(ies), maternal medical condition, other, not documented.	42 weeks project estimated gestational age or less	No
Secondary	Spontaneous pregnancy loss less than 20 weeks	Fetal death leading to vaginal delivery or dilatation and curettage/evacuation, or spontaneous expulsion of a liveborn fetus due to any cause before 20 weeks 0 days project EGA.	42 weeks project estimated gestational age or less	No