Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
182 participants
OBSERVATIONAL
2008-08-31
2012-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Sleep Apnea Syndrome in Obese Women During Pregnancy
NCT03509805
Snoring in Pregnancy and Adverse Maternal and Fetal Outcomes
NCT01030003
Correlation Between Preeclampsia and Positive for Obstructive Sleep Apnea Screening Test: STOPBANG Questionnaire
NCT02800798
Sleep Quality in Pregnancy and Its Impact on Pregnancy Outcomes
NCT02016638
Obstructive Sleep Apnea Treatment and Insulin Sensitivity in Pregnancy
NCT04013399
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Women with sleep apnea
No interventions assigned to this group
Women without sleep apnea
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Singleton pregnancy
* 18 years or older
Exclusion Criteria
* Inability to sleep beyond 2 hours
* 3 or more missed prenatal visits
18 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Robert Wood Johnson Foundation
OTHER
MetroHealth Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Judette Louis, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
MetroHealth Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
MetroHealth Medical Center
Cleveland, Ohio, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RWJ64323
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.