Sleep Apnea in Pregnancy Screening Study (SAPSS)

November 10, 2023 updated by: MetroHealth Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

182

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44109
        • MetroHealth Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Obstetric care clinic at a tertiary care hospital

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Women with sleep apnea
Women without sleep apnea

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Subjects will be followed for the duration of their pregnancy and postpartum period, an expected average of 26 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
Time Frame: Subjects will be followed for the duration of their pregnancy and postpartum period, an expected average of 26 weeks
Subjects will be followed for the duration of their pregnancy and postpartum period, an expected average of 26 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MetroHealth Medical Center

Collaborators

Robert Wood Johnson Foundation

Investigators

  • Principal Investigator: Judette Louis, MD, MPH, MetroHealth Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

April 23, 2012

First Submitted That Met QC Criteria

April 25, 2012

First Posted (Estimated)

April 26, 2012

Study Record Updates

Last Update Posted (Actual)

November 14, 2023

Last Update Submitted That Met QC Criteria

November 10, 2023

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RWJ64323

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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