NCT01585844|Completed
Sleep Apnea in Pregnancy Screening Study
SAPSS
Obstructive Sleep Apnea in Pregnancy:Epidemiology and Maternal/ Neonatal Morbidity
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SAPSS
Obstructive Sleep Apnea in Pregnancy:Epidemiology and Maternal/ Neonatal Morbidity
Sponsor study identifier
observational
182
1 country
1
Study Start
August 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2012
Actual (reported)Study Completion
April 2012
Actual (reported)Obstructive sleep apnea is known to be a significant source of morbidity in the general population. It has been proposed to be associated with the development of preeclampsia and fetal growth restriction. As these are conditions that have long term maternal and neonatal implications, further information may help improve maternal/fetal outcome. One reason why women and in particular pregnant women are under diagnosed is the lack of an effective, reliable screening tool. Validated questionnaires used in the general population may not be effective in screening pregnant women. The investigators hypothesize that sleep apnea will have 20% prevalence in the obese pregnant population and that it is associated with increased maternal and neonatal morbidity. The investigators will recruit obese pregnant women in their prenatal care clinics and they will be screened for OSA using validated sleep questionnaires including the Epworth sleepiness scale, the Fatigue Scale and the Berlin Questionnaire. The subjects will then perform overnight apnea monitoring utilizing a portable sleep apnea detection device. Women who meet clinical criteria for OSA will be referred for overnight polysomnogram and management by the Pulmonary and Critical Care Division of the Internal Medicine Department. For all enrolled patients the remainder of prenatal care will be per routine. Data will be collected regarding the pregnancy course and outcomes. The primary outcome of interest is the prevalence of sleep apnea in obese women and the associated maternal and neonatal morbidity. The secondary outcome measures will be molecular measures of systemic inflammation, oxidative stress and angiogenesis associated with sleep apnea.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2012
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2008
Date type not reportedThis date has not been verified as actual or estimated.
April 2012
Actual (reported)April 2012
Actual (reported)April 23, 2012
Actual (reported)April 26, 2012
Actual (reported)The prevalence of sleep apnea in obese pregnant women
Subjects will be followed for the duration of their pregnancy and postpartum period, an expected average of 26 weeks
Alterations in biomarkers of inflammation and oxidative stress
Subjects will be followed for the duration of their pregnancy and postpartum period, an expected average of 26 weeks
The prevalence of maternal and neonatal morbidity
Subjects will be followed for the duration of their pregnancy and postpartum period, an expected average of 26 weeks
Obstetric care clinic at a tertiary care hospital
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
Connolly G, Razak AR, Hayanga A, Russell A, McKenna P, McNicholas WT. Inspiratory flow limitation during sleep in pre-eclampsia: comparison with normal pregnant and nonpregnant women. Eur Respir J. 2001 Oct;18(4):672-6. doi: 10.1183/09031936.01.00053501.
Young T, Peppard PE, Gottlieb DJ. Epidemiology of obstructive sleep apnea: a population health perspective. Am J Respir Crit Care Med. 2002 May 1;165(9):1217-39. doi: 10.1164/rccm.2109080.
urine serum
Judette Louis, MD, MPH
MetroHealth Medical Center
182 participants (actual enrollment reported by the registry).
First Submitted
April 23, 2012
First Posted
April 26, 2012
Study Start
August 2008
Date type not reportedThis date has not been verified as actual or estimated.
Respiratory and Autonomic Plasticity Following Intermittent Hypoxia
Enabling Sleep Apnea Patient-Centered Care Via an Internet Intervention
Contact the study team to confirm eligibility.
Young T, Palta M, Dempsey J, Skatrud J, Weber S, Badr S. The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med. 1993 Apr 29;328(17):1230-5. doi: 10.1056/NEJM199304293281704.
Joel-Cohen SJ, Schoenfeld A. Fetal response to periodic sleep apnea: a new syndrome in obstetrics. Eur J Obstet Gynecol Reprod Biol. 1978 Apr;8(2):77-81. doi: 10.1016/0028-2243(78)90131-4.
Franklin KA, Holmgren PA, Jonsson F, Poromaa N, Stenlund H, Svanborg E. Snoring, pregnancy-induced hypertension, and growth retardation of the fetus. Chest. 2000 Jan;117(1):137-41. doi: 10.1378/chest.117.1.137.
Charbonneau M, Falcone T, Cosio MG, Levy RD. Obstructive sleep apnea during pregnancy. Therapy and implications for fetal health. Am Rev Respir Dis. 1991 Aug;144(2):461-3. doi: 10.1164/ajrccm/144.2.461.
Louis JM, Auckley D, Sokol RJ, Mercer BM. Maternal and neonatal morbidities associated with obstructive sleep apnea complicating pregnancy. Am J Obstet Gynecol. 2010 Mar;202(3):261.e1-5. doi: 10.1016/j.ajog.2009.10.867. Epub 2009 Dec 14.
Pien GW, Fife D, Pack AI, Nkwuo JE, Schwab RJ. Changes in symptoms of sleep-disordered breathing during pregnancy. Sleep. 2005 Oct;28(10):1299-305. doi: 10.1093/sleep/28.10.1299.
Primary Completion
April 2012
Actual (reported)Study Completion
April 2012
Actual (reported)Last Updated
November 14, 2023
Record last verified: 2012-04
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