Francesca L Facco1, Corette B Parker2, Uma M Reddy3, Robert M Silver4, Judette M Louis5, Robert C Basner6, Judith H Chung7, Frank P Schubert8, Grace W Pien9, Susan Redline10, Daniel R Mobley11, Matthew A Koch2, Hyagriv N Simhan12, Chia-Ling Nhan-Chang13, Samuel Parry14, William A Grobman15, David M Haas8, Deborah A Wing7, Brian M Mercer5, George R Saade16, Phyllis C Zee17. 1. Department of Obstetrics and Gynecology, Magee-Womens Research Institute & Foundation, University of Pittsburgh School of Medicine, Pittsburgh, PA. Electronic address: faccof@upmc.edu. 2. RTI International, Research Triangle Park, NC. 3. Pregnancy and Perinatology Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD. 4. Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Utah Health Sciences Center, Salt Lake City, UT. 5. Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Case Western Reserve University School of Medicine, Cleveland, OH. 6. Department of Clinical Medicine, College of Physicians and Surgeons, Columbia University, New York, NY. 7. Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of California, Irvine, School of Medicine, Irvine, CA. 8. Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Indiana University School of Medicine, Indianapolis, IN. 9. Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD. 10. Departments of Medicine and Neurology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA. 11. Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA. 12. Department of Obstetrics and Gynecology, Magee-Womens Research Institute & Foundation, University of Pittsburgh School of Medicine, Pittsburgh, PA. 13. Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, College of Physicians and Surgeons, Columbia University, New York, NY. 14. Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Pennsylvania School of Medicine, Philadelphia, PA. 15. Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Northwestern University Feinberg School of Medicine, Chicago, IL. 16. Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Texas Medical Branch, Galveston, TX. 17. Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL.
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 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. 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.
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 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. 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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