Sleep Apnea Syndrome in Obese Women During Pregnancy

April 17, 2026 updated by: University Hospital, Lille

Excess weight or obesity is associated with an increased risk of health disorders: high blood pressure, diabetes, cardiovascular risks, dyslipidemia and sleep apneas. During pregnancy in obese women, the risk of preeclampsia increases by three and the risk of fetal death in utero by five. Snoring and Obstructive sleep apnea (OSA) may be associated with increased risk of adverse pregnancy outcomes, including maternal cardio pulmonary status, fetal heart rate and fetal acidosis-basis status by recurrent upper-airway obstruction, hypoventilation, and intermittent nocturnal hypoxia. Reports in pregnancy have identified in association with OSA and preeclampsia, intrauterine growth restriction and stillbirth.

The prevalence of OSA among women is estimated to be 2-5%, but it remains underdiagnosed during pregnancy. In sleep apnea syndrome, a few data have shown better pregnancy and fetal outcome with the use continuous positive airway pressure (CPAP) therapy.

the hypothesis is in obese pregnant women that there could be a significant association between sleep apnea syndrome and hypertensive disorders, preeclampsia and adverse fetal outcomes This is a prospective study of Women with a body mass index of 35 kg.m2 or greater. The aim of this study is to determinate the prevalence of sleep apnea syndrome in obese pregnant women and the benefit of CPAP on the maternal and fetal outcome.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

89

Phase

  • Not Applicable

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

  • France
    • North
      • Lille, North, France, 59037
        • CHRU,Hôpital Jeanne de Flandre

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

Description

Inclusion Criteria:

  • age >18 years
  • BMI > 35
  • > 24th weeks of pregnancy
  • informed consent,
  • health assurance

Exclusion Criteria:

  • no informed consent
  • twin pregnancy or more
  • no health assurance

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

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OSA in obese patient during pregnancy
OSA in polysomnography
Diagnostic test: polysomnography
Experimental: no OSA in obese patient during pregnancy
no OSA in polysomnography
Diagnostic test: polysomnography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurrence of apnea objectified by polysomnography according to specific neurophysiological criteria
Time Frame: during the sleep time, an average 8 hours
during the sleep time, an average 8 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
occurrence of vascular disease
Time Frame: from inclusion at the beginning of the management of pregnancy to delivery
High blood pressure (HTAG), Essential or chronic hypertension, preeclampsia, Severe preeclampsia
from inclusion at the beginning of the management of pregnancy to delivery
Evaluation of fetal impact by correlation of birth weight to gestational age
Time Frame: from inclusion at the beginning of the management of pregnancy to delivery
from inclusion at the beginning of the management of pregnancy to delivery

Collaborators and Investigators

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

Sponsor

University Hospital, Lille

Investigators

  • Principal Investigator: Anne-Frédérique Dalmas, MD, University Hospital, Lille

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 (Actual)

September 1, 2010

Primary Completion (Actual)

March 14, 2017

Study Completion (Actual)

March 14, 2017

Study Registration Dates

First Submitted

April 24, 2018

First Submitted That Met QC Criteria

April 25, 2018

First Posted (Actual)

April 26, 2018

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 17, 2026

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008_32
  • 2009-A01018-49 (Other Identifier: ID-RCB number, ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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