Sleep Apnea, Obesity and Pregnancy

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02029859

Acronym

GOS

Enrollment

205

Registered

2014-01-08

Start date

2011-04-30

Completion date

2015-03-31

Last updated

2015-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Pregnancy

Keywords

pregnancy (after 30 weeks of amenorhea), obesity (BMI>35), sleep apnea syndrom, preeclampsy, intrauterine growth restriction

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.

Interventions

PROCEDUREPolygraphic examination

Polygraphic examination between 30 and 36 weeks of amenorhea

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* BMI \>35 * 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

Design outcomes

Primary

Measure	Time frame	Description
Sleep apnea syndrom prevalence	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).

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026