Sleep Apnea, Obesity and Pregnancy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

205 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2015-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Obesity and OSA in Pregnancy

NCT05654259

Obesity Obesity, Maternal Obstructive Sleep Apnea +1 more

COMPLETED

Prevalence Study and Identification of Factors Prognosis of Obstructive Sleep Apnea Syndrome Sleep in Pregnant Women

NCT05725642

Pregnancy Related

NOT_YET_RECRUITING

Detection of Sleep Apnea Syndrome (OSA) in Pregnant Women and Assessment of Impact of OSA on Pregnancy Course

NCT02649933

Pregnancy Sleep Apnea Syndrome Obstructive Sleep Apnea

TERMINATED

Incidence of Obstructive Sleep Apnea in Pregnancy

NCT00462306

Obstructive Sleep Apnea Pregnancy

COMPLETED

Obstructive Sleep Apnea in Pregnancy

NCT02383706

Sleep Apnea, Obstructive Pregnancy Obesity, Morbid

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity Pregnancy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Polygraphic examination

Intervention Type PROCEDURE

Polygraphic examination between 30 and 36 weeks of amenorhea

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Polygraphic examination

Polygraphic examination between 30 and 36 weeks of amenorhea

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No