- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05725642
Prevalence Study and Identification of Factors Prognosis of Obstructive Sleep Apnea Syndrome Sleep in Pregnant Women (SAOSPRONOS)
The exact prevalence of sleep-disordered breathing in pregnant women is not known. The results of a analysis of a small cohort of 105 pregnant women adjusted to body mass index estimate a prevalence of 8.4% in first quarter and 19.7% in the third quarter.
In this context, this study proposes to assess the prevalence of sleep-disordered breathing in pregnant women of the Private Hospital of the Loire and to identify the risks associated with these disorders by systematically proposing a polysomnography.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Pregnancy brings physical and hormonal changes and sleep is impaired by heartburn, cramps, frequent urination, fetal movements... Snoring is commonly observed in pregnant women at the end of the second and third trimester. Snoring can be a manifestation of OSAS. It has been shown that the apnea-hypopnea index (AHI) increases during pregnancy, at the third quarter. Physiological changes associated with pregnancy increase the risk of OSAS. In pregnant women, sleep deprivation leads to increased risk of gestational diabetes, high blood pressure, preeclampsia and antenatal depression, but also a risk of premature delivery or having a child with a delay in growth.
Finally, the exact prevalence of sleep-disordered breathing in pregnant women is not known. The results of a analysis of a small cohort of 105 pregnant women adjusted to body mass index estimate a prevalence of 8.4% in first quarter and 19.7% in the third quarter.
In this context, this study proposes to assess the prevalence of sleep-disordered breathing in pregnant women of the Private Hospital of the Loire and to identify the risks associated with these disorders by systematically proposing a polysomnography.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Anne-Hélène GIRAUD, MD
- Phone Number: + 33 9 81 60 86 90
- Email: annehelenegiraud@yahoo.fr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Pregnant woman aged 18 and over.
- Pregnant woman who has not yet completed her consultation of the 1st quarter.
- Woman accepting the achievement of, at most, 2 polysomnographies.
- Affiliated participant or beneficiary of a security regime social.
- Participant having been informed of the study and not objecting to the use of her data.
- Authorization to collect and use the baby's data.
Exclusion Criteria:
- Participation in another clinical study.
- Participant with protected status: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision.
- Participant hospitalized without consent
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
OSAS Diagnosis with polysomnography
Time Frame: 9 months
|
Diagnosis of OSAS with polysomnography, prior to the study, or during the first 2 trimesters of pregnancy
|
9 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-A00981-42
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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