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Sleep Apnea, Obesity and Pregnancy (GOS)

U

University Hospital, Rouen

Status

Completed

Conditions

Obesity
Pregnancy

Treatments

Procedure: Polygraphic examination

Study type

Interventional

Funder types

Other

Identifiers

NCT02029859
2009/070/HP

Details and patient eligibility

About

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.

Enrollment

205 patients

Sex

Female

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

205 participants in 1 patient group

Prevalence of obstructive sleep apnea syndrome
Experimental group
Description:
Determine the prevalence of obstructive sleep apnea syndrome (OSA) in late pregnancy in a population of obese patients . Polygraphic examination between 30 and 36 weeks of amenorhea
Treatment:
Procedure: Polygraphic examination

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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