NuMoM2b Sleep-Disordered Breathing study: objectives and methods - 02/04/15

Doi : 10.1016/j.ajog.2015.01.021

Francesca L. Facco, MD, MS ^a,^⁎ , Corette B. Parker, DrPH ^c, Uma M. Reddy, MD, MPH ^d, Robert M. Silver, MD ^f, Judette M. Louis, MD, MPH ^g, Robert C. Basner, MD ^h, Judith H. Chung, MD, PhD ^j, Frank P. Schubert, MD, MS ^k, Grace W. Pien, MD, MSCE ^e, Susan Redline, MD, MPH ^l, Daniel R. Mobley, RPSGT ^m, Matthew A. Koch, MD, PhD ^c, Hyagriv N. Simhan, MD, MS ^a, Chia-Ling Nhan-Chang, MD, MS ⁱ, Samuel Parry, MD ^b, William A. Grobman, MD, MBA ⁿ, David M. Haas, MD, MS ^k, Deborah A. Wing, MD ^j, Brian M. Mercer, MD ^g, George R. Saade, MD ^p, Phyllis C. Zee, MD, PhD ^o
^a Department of Obstetrics and Gynecology, Magee-Womens Research Institute & Foundation, University of Pittsburgh School of Medicine, Pittsburgh, PA
^b Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Pennsylvania School of Medicine, Philadelphia, PA
^c RTI International, Research Triangle Park, NC
^d Pregnancy and Perinatology Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD
^e Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD
^f Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Utah Health Sciences Center, Salt Lake City, UT
^g Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Case Western Reserve University School of Medicine, Cleveland, OH
^h Department of Clinical Medicine, College of Physicians and Surgeons, Columbia University, New York, NY
ⁱ Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, College of Physicians and Surgeons, Columbia University, New York, NY
^j Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of California, Irvine, School of Medicine, Irvine, CA
^k Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Indiana University School of Medicine, Indianapolis, IN
^l Departments of Medicine and Neurology, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA
^m Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA
ⁿ Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Northwestern University Feinberg School of Medicine, Chicago, IL
^o Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL
^p Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Texas Medical Branch, Galveston, TX

^∗Corresponding author: Francesca Facco, MD.

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.

Study Design

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 6⁰-15⁰ weeks’ gestation (visit 1) and again between 22⁰-31⁰ 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.

Conclusion

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.

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Key words : home sleep test, methods, pregnancy, sleep-disordered breathing, sleep

Plan

Methods

The nuMoM2b parent study

Aims and hypotheses

Design

Scoring and quality control

Blinding and urgent alerts

Power and sample size

Results

Comment

	Supported by Supported by grant funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the National Heart Lung and Blood Institute: U10 HD063036, Research Triangle Institute; U10 HD063072, Case Western Reserve University; U10 HD063047, Columbia University; U10 HD063037, Indiana University; U10 HD063041, Magee-Women’s Hospital; U10 HD063020, Northwestern University; U10 HD063046, University of California Irvine; U10 HD063048, University of Pennsylvania; and U10 HD063053, University of Utah.
	The authors report no conflict of interest.
	Cite this article as: Facco FL, Parker CB, Reddy UM, et al. NuMoM2b sleep-disordered breathing study: objectives and methods. Am J Obstet Gynecol 2015;212:542.e1-128.

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Vol 212 - N° 4

P. 542.e1-542.e127 - avril 2015 Retour au numéro

Article précédent

A description of the methods of the Nulliparous Pregnancy Outcomes Study: monitoring mothers-to-be (nuMoM2b)
David M. Haas, Corette B. Parker, Deborah A. Wing, Samuel Parry, William A. Grobman, Brian M. Mercer, Hyagriv N. Simhan, Matthew K. Hoffman, Robert M. Silver, Pathik Wadhwa, Jay D. Iams, Matthew A. Koch, Steve N. Caritis, Ronald J. Wapner, M. Sean Esplin, Michal A. Elovitz, Tatiana Foroud, Alan M. Peaceman, George R. Saade, Marian Willinger, Uma M. Reddy, NuMoM2b study

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NuMoM2b Sleep-Disordered Breathing study: objectives and methods - 02/04/15

Abstract

Objective

Study Design

Results

Conclusion

Plan

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