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CompletedNCT02029859GOSUpdated Jun 3, 2015

Sleep Apnea, Obesity and Pregnancy

An interventional study of Polygraphic examination in Obesity and Pregnancy, sponsored by University Hospital, Rouen. Completed at 4 sites in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-06-03.

Sponsored by University Hospital, Rouen · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
205
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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.
02

Conditions studied

  • Obesity
  • Pregnancy

Keywords

  • pregnancy (after 30 weeks of amenorhea)
  • obesity (BMI>35)
  • sleep apnea syndrom
  • preeclampsy
  • intrauterine growth restriction
03

In context

Sleep Apnea Syndromes

2,162 studies on the registry are indexed under Sleep Apnea Syndromes; 290 are open to participants now.

This study's enrollment of 205 is above the median of 53 across 1,386 interventional studies indexed under Sleep Apnea Syndromes.

Browse Sleep Apnea Syndromes studies →

Lead sponsor

University Hospital, Rouen is the lead sponsor of 410 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • BMI >35
  • Pregnancy after 30 Weeks of amenorhea
  • Age > 18
  • Signed consentment
  • Nationnal Health Program affiliation

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
205 participants (actual)

Study arms

  • Experimental
    Prevalence of obstructive sleep apnea syndrome

    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

    Procedure: Polygraphic examination

Interventions

  • ProcedurePolygraphic examination

    Polygraphic examination between 30 and 36 weeks of amenorhea

06

What researchers measure

Primary outcomes

  1. Sleep apnea syndrom prevalence

    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).

    Time frame: 6 weeks

07

Study locations

4 sites
  • Angers University Hospital
    Angers, 49000, France
  • Caen University Hospital
    Caen, 14000, France
  • Le Havre Hospital
    Le Havre, 76290, France
  • Rouen University Hospital
    Rouen, 76000, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 3, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02029859
Lead sponsor
University Hospital, Rouen
Responsible party
Sponsor
First posted
Jan 8, 2014
Start date
Apr 2011
Primary completion
Jul 2014
Completion
Mar 2015
Last update
Jun 3, 2015

Study contacts

Loic Marpeau, PHD
principal investigator · Rouen University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.

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