Sleep Apnea in Pregnancy Screening Study (SAPSS)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition |
|---|
|
Sleep Apnea Obesity |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Obstructive Sleep Apnea in Pregnancy:Epidemiology and Maternal/ Neonatal Morbidity |
- The prevalence of sleep apnea in obese pregnant women [ Time Frame: Subjects will be followed for the duration of their pregnancy and postpartum period, an expected average of 26 weeks ] [ Designated as safety issue: No ]
- Alterations in biomarkers of inflammation and oxidative stress [ Time Frame: Subjects will be followed for the duration of their pregnancy and postpartum period, an expected average of 26 weeks ] [ Designated as safety issue: No ]
- The prevalence of maternal and neonatal morbidity [ Time Frame: Subjects will be followed for the duration of their pregnancy and postpartum period, an expected average of 26 weeks ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
urine serum
| Enrollment: | 182 |
| Study Start Date: | August 2008 |
| Study Completion Date: | April 2012 |
| Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Women with sleep apnea |
| Women without sleep apnea |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Obstetric care clinic at a tertiary care hospital
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
Contacts and Locations| United States, Ohio | |
| MetroHealth Medical Center | |
| Cleveland, Ohio, United States, 44109 | |
| Principal Investigator: | Judette Louis, MD, MPH | MetroHealth Medical Center |
More Information
Publications:
| Responsible Party: | Judette Louis, Assistant Professor, Reproductive Biology, MetroHealth Medical Center |
| ClinicalTrials.gov Identifier: | NCT01585844 History of Changes |
| Other Study ID Numbers: | RWJ64323 |
| Study First Received: | April 23, 2012 |
| Last Updated: | April 25, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by MetroHealth Medical Center:
|
sleep apnea pregnancy obesity |
Additional relevant MeSH terms:
|
Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Disorders Obesity Respiration Disorders Respiratory Tract Diseases |
Signs and Symptoms, Respiratory Signs and Symptoms Overnutrition Nutrition Disorders Overweight Body Weight Dyssomnias Nervous System Diseases |
ClinicalTrials.gov processed this record on June 17, 2013