Sleep Apnea in Pregnancy Screening Study

Obesity Clinical Trial

— SAPSS  

Official title:

Obstructive Sleep Apnea in Pregnancy:Epidemiology and Maternal/ Neonatal Morbidity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01585844
• Other study ID #: RWJ64323
• Status: Completed
• Start date: August 2008
• Est. completion date: April 2012

Study information

• Verified date: April 2012
• Source: MetroHealth Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Prepregnancy BMI of 30kg/m2 or greater

• Singleton pregnancy

• 18 years or older

Exclusion Criteria:

• Chronic use of narcotics or other CNS drugs

• Inability to sleep beyond 2 hours

• 3 or more missed prenatal visits

Related Conditions & MeSH terms

• Apnea
• Obesity
• Sleep Apnea
• Sleep Apnea Syndromes

Locations

Country	Name	City	State
United States	MetroHealth Medical Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
MetroHealth Medical Center	Robert Wood Johnson Foundation

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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