NuMoM2b Sleep-Disordered Breathing study: objectives and methods.
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 that was 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 6(0)-15(0) weeks' gestation (visit 1) and again between 22(0)-31(0) weeks' gestation (visit 3). Scoring of tests was conducted by a central Sleep Reading Center. Participants and their health care providers were notified if test results met "urgent referral" criteria that were based on threshold levels of apnea hypopnea indices, oxygen saturation levels, or electrocardiogram abnormalities but were not notified of test results otherwise. The primary pregnancy outcomes to be analyzed in relation to maternal sleep disordered breathing are preeclampsia, gestational hypertension, gestational diabetes mellitus, fetal growth restriction, and preterm birth.


RESULTS
Objective data were obtained at visit 1 on 3261 women, which was 88.1% of the studies that were attempted and at visit 3 on 2511 women, which was 87.6% of the studies that were attempted. Basic characteristics of the substudy cohort are reported in this methods article.


CONCLUSIONS
The substudy was 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.
Department of Obstetrics and Gynecology, Magee-Womens Research Institute & Foundation, University of Pittsburgh School of Medicine, Pittsburgh, PA. Electronic address: faccof@upmc.edu.
Francesca L
FL
Facco
RTI International, Research Triangle Park, NC.
Corette B
CB
Parker
Pregnancy and Perinatology Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD.
Uma M
UM
Reddy
Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Utah Health Sciences Center, Salt Lake City, UT.
Robert M
RM
Silver
Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Case Western Reserve University School of Medicine, Cleveland, OH.
Judette M
JM
Louis
Department of Clinical Medicine, College of Physicians and Surgeons, Columbia University, New York, NY.
Robert C
RC
Basner
Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of California, Irvine, School of Medicine, Irvine, CA.
Judith H
JH
Chung
Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Indiana University School of Medicine, Indianapolis, IN.
Frank P
FP
Schubert
Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD.
Grace W
GW
Pien
Departments of Medicine and Neurology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.
Susan
S
Redline
Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA.
Daniel R
DR
Mobley
RTI International, Research Triangle Park, NC.
Matthew A
MA
Koch
Department of Obstetrics and Gynecology, Magee-Womens Research Institute & Foundation, University of Pittsburgh School of Medicine, Pittsburgh, PA.
Hyagriv N
HN
Simhan
Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, College of Physicians and Surgeons, Columbia University, New York, NY.
Chia-Ling
CL
Nhan-Chang
Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Pennsylvania School of Medicine, Philadelphia, PA.
Samuel
S
Parry
Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Northwestern University Feinberg School of Medicine, Chicago, IL.
William A
WA
Grobman
Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Indiana University School of Medicine, Indianapolis, IN.
David M
DM
Haas
Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of California, Irvine, School of Medicine, Irvine, CA.
Deborah A
DA
Wing
Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Case Western Reserve University School of Medicine, Cleveland, OH.
Brian M
BM
Mercer
Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Texas Medical Branch, Galveston, TX.
George R
GR
Saade
Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL.
Phyllis C
PC
Zee
D000293:Adolescent; D000328:Adult; D002985:Clinical Protocols; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D017286:Polysomnography; D011247:Pregnancy; D011248:Pregnancy Complications / Q000175:diagnosis / Q000209:etiology*; D011256:Pregnancy Outcome; D011446:Prospective Studies; D012107:Research Design; D012307:Risk Factors; D012891:Sleep Apnea Syndromes / Q000150:complications* / Q000175:diagnosis; D055815:Young Adult
home sleep test; methods; pregnancy; sleep; sleep-disordered breathing