NCT02029859

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
205

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Apr 2011

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

January 6, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 8, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

June 3, 2015

Status Verified

June 1, 2015

Enrollment Period

3.3 years

First QC Date

January 6, 2014

Last Update Submit

June 2, 2015

Conditions

ObesityPregnancy

Keywords

pregnancy (after 30 weeks of amenorhea)obesity (BMI>35)sleep apnea syndrompreeclampsyintrauterine growth restriction

Outcome Measures

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).

    6 weeks

Study Arms (1)

Prevalence of obstructive sleep apnea syndrome

EXPERIMENTAL

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

Polygraphic examinationPROCEDURE

Polygraphic examination between 30 and 36 weeks of amenorhea

Prevalence of obstructive sleep apnea syndrome

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Angers University Hospital

Angers, 49000, France

Location

Caen University Hospital

Caen, 14000, France

Location

Le Havre Hospital

Le Havre, 76290, France

Location

Rouen University Hospital

Rouen, 76000, France

Location

MeSH Terms

Conditions

ObesityFetal Growth Retardation

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsFetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGrowth DisordersPathologic Processes

Study Officials

  • Loic Marpeau, PHD

    University Hospital, Rouen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2014

First Posted

January 8, 2014

Study Start

April 1, 2011

Primary Completion

July 1, 2014

Study Completion

March 1, 2015

Last Updated

June 3, 2015

Record last verified: 2015-06

Locations

FR(4)