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Clinical Trials/NCT02029859
NCT02029859
Completed
Not Applicable

Sleep Apnea, Obesity and Pregnancy

University Hospital, Rouen4 sites in 1 country205 target enrollmentApril 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
University Hospital, Rouen
Enrollment
205
Locations
4
Primary Endpoint
Sleep apnea syndrom prevalence
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

Main objective:

Determine the prevalence of obstructive sleep apnea syndrome (OSA) in late pregnancy in a population of obese patients .

Secondary objectives :

  • Identify risk factors for OSA during pregnancy (age, parity, high blood pressure, snoring , weight, neck circumference, scores on symptoms of sleep apnea, ... ) .
  • Compare perinatal morbidity among obese patients with OSA in late pregnancy with case-controls.
  • Evaluate the evolution of a moderate or severe OSA 6 months after pregnancy.

Material and methods

Characteristics of the study:

  • Interventional biomedical research
  • Prospective Multicenter nonrandomized study

Flow chart

  • Patients will be included between 30 and 36 weeks of amenorrhea (WA) .
  • Will rated from inclusion: age, parity, weight, height, BMI in early pregnancy, neck circumferrence, treated high blood pressure.
  • As recommended in France, the main test results during the pregnancy follow-up will be recorded.
  • At the inclusion visit will be conducted a Berlin Questionnaire and Epworth Score.
  • Screening for OSA by nocturnal polysomnography will be performed between 30 and 36WA. This screening can be performed as an outpatient.
  • In case of proven OSA patients will be offered an appropriate care by today's standards.
  • Whatever the outcome of pregnancy, a second polysomnography will be performed 6 months after childbirth in case of OSA during pregnancy.
Registry
clinicaltrials.gov
Start Date
April 2011
End Date
March 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Sponsor
University Hospital, Rouen
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Pregnancy after 30 Weeks of amenorhea
  • Age \> 18
  • Signed consentment
  • Nationnal Health Program affiliation

Exclusion Criteria

  • Twin or more pregnancy
  • Imprecise term
  • Artificial insemination with donor gametes
  • Proved thrombophilia
  • chronic renal failure
  • Previously treated (with CPAP) obstructive sleep apnea syndrom

Outcomes

Primary Outcomes

Sleep apnea syndrom prevalence

Time Frame: 6 weeks

Polygraphic examination for all subjects will determine the sleep apnea syndrom prevalence during late pregnancy (after 30 weeks of amenorhea) for severe obese women (BMI\>35).

Study Sites (4)

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