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OpenTrials
Completed

NCT Number: NCT02029859

Sleep Apnea, Obesity and Pregnancy

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.

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Key information

Conditions

Obesity Body Weight Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Fetal Diseases Fetal Growth Retardation Growth Disorders Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Pregnancy Complications Signs and Symptoms Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Angers University Hospital, Angers, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polygraphic examination

Procedure

Polygraphic examination between 30 and 36 weeks of amenorhea

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Acronym: GOS

Important dates

Study start
2011
Primary completion
2014
Study completion
2015
First posted
Jan 8, 2014
Registry last updated
Jun 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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