Clinical trial NCT01585844: Sleep Apnea in Pregnancy Screening Study
Official title: Obstructive Sleep Apnea in Pregnancy:Epidemiology and Maternal/ Neonatal Morbidity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Apnea
Obesity
Keywords: sleep apnea
pregnancy
obesity
Lead sponsor: MetroHealth Medical Center
Sponsor class: OTHER
Collaborators: name: Robert Wood Johnson Foundation
First posted: 2012-04-26
Enrollment: 182
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Obstetric care clinic at a tertiary care hospital

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: The prevalence of sleep apnea in obese pregnant women
timeFrame: Subjects will be followed for the duration of their pregnancy and postpartum period, an expected average of 26 weeks
Secondary outcomes:
measure: Alterations in biomarkers of inflammation and oxidative stress
timeFrame: Subjects will be followed for the duration of their pregnancy and postpartum period, an expected average of 26 weeks
measure: The prevalence of maternal and neonatal morbidity
timeFrame: Subjects will be followed for the duration of their pregnancy and postpartum period, an expected average of 26 weeks
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
Study officials:
affiliation: MetroHealth Medical Center
name: Judette Louis, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
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.
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.