NuMoM2b Sleep-Disordered Breathing study: objectives and methods

Abstract

Objective The objective of the Sleep Disordered Breathing substudy of the Nulliparous Pregnancy Outcomes Study Monitoring Mothers-to-be (nuMoM2b) is to determine whether sleep disordered breathing during pregnancy is a risk factor for adverse pregnancy outcomes. Methods nuMoM2b is a prospective cohort study of 10,037 nulliparous women with singleton gestations, conducted across 8 sites, with a central Data Coordinating and Analysis Center. The Sleep Disordered Breathing substudy recruited 3702 women from the cohort to undergo objective, overnight in-home assessments of sleep disordered breathing. A standardized Level 3 home sleep test was performed between 60–150 weeks of pregnancy (Visit 1) and again between 220–310 weeks of pregnancy (Visit 3). Scorings of tests were conducted by a central Sleep Reading Center. Participants and their health care providers were notified if test results met “urgent referral” criteria based on threshold levels of apnea hypopnea indices, oxygen saturation levels or ECG abnormalities, but otherwise were not notified of test results. The primary pregnancy outcomes to be analyzed in relation to maternal sleep disordered breathing are preeclampsia, gestational hypertension, gestational diabetes, fetal growth restriction, and preterm birth. Results Objective data were obtained at Visit 1 on 3261 women, 88.1% of studies attempted; and at Visit 3 on 2511 women, 87.6% of studies attempted. Basic characteristics of the substudy cohort are reported in this methods paper. Conclusion The substudy is designed to address important questions regarding the relationship of sleep disordered breathing on the risk of preeclampsia and other outcomes of relevance to maternal and child health.

Women with postpartum weight retention have delayed wake times and decreased sleep efficiency during the perinatal period: a brief report

“…Another limitation is the reliance on self-reported pre-pregnancy weight. We anticipate that larger, prospective cohort studies of perinatal women (e.g., NuMom2B (26)) will seek to confirm the preliminary observations reported here.…”

Association Between Sleep-Disordered Breathing and Hypertensive Disorders of Pregnancy and Gestational Diabetes Mellitus

“…2021 Briefly, the Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-Be parent study was conducted at 8 clinical sites and managed by an independent Data Coordinating Center. Inclusion criteria for the parent study were nulliparity (no prior delivery ≥20 weeks’ gestation) and a viable singleton pregnancy at the time of screening (6 0 –13 6 weeks’ gestation).…”

Role of early second-trimester uterine artery Doppler screening to predict small-for-gestational-age babies in nulliparous women

“…Definitions for preeclampsia and antepartum gestational hypertension in the nuMoM2b study have been published previously. 17 Briefly, antepartum gestational hypertension was defined as new onset hypertension that was ≥140 mm Hg systolic or ≥90 mm Hg diastolic on two occasions at least six hours apart after 20 weeks 0 days gestation and prior to labor and delivery. Preeclampsia included eclampsia, mild and severe preeclampsia, and superimposed preeclampsia.…”

“…Preeclampsia included eclampsia, mild and severe preeclampsia, and superimposed preeclampsia. 17 Spontaneous preterm births were defined as women who delivered at 20 weeks 0 days to 36 weeks 6 days secondary to preterm labor or preterm premature rupture of membranes. Stillbirth was a fetal death at an estimated gestational age of 20 weeks 0 days or greater with Apgar scores of 0 at 1, 5, and 10 minutes with no other signs of life by direct observation.…”

“…17,18 More than 10,000 women with singleton pregnancies were enrolled in the nuMoM2b study, which combined detailed demographic and medical information, clinical parameters, ultrasound measurements, genetics, biomarker measurements in biologic fluids, and psychosocial and behavioral measures in both pre-specified and exploratory analyses to identify pregnant women at risk for adverse pregnancy outcomes. 17,18 Uterine artery Doppler studies were performed for all nuMoM2b subjects during the second trimester of pregnancy in order to study the relationship between uterine artery compliance and adverse pregnancy outcomes attributed to placental dysfunction, including SGA birth weights and preeclampsia. The objective of the current analysis was to determine the utility of early second trimester maternal uterine artery Doppler study measures as predictors of SGA babies.…”