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

NCT05725642 | Not Yet Recruiting

• 1 other identifier: 2022-A00981-42
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pregnancy Related

Outcome Measures

Primary Outcomes (1)

• OSAS Diagnosis with polysomnography

  Diagnosis of OSAS with polysomnography, prior to the study, or during the first 2 trimesters of pregnancy

  9 months

Interventions

Polysomnography OTHER

Polysomnography

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead

Central Study Contacts

Anne-Hélène GIRAUD, MD

CONTACT

+ 33 9 81 60 86 90; annehelenegiraud@yahoo.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2023
• First Posted: February 13, 2023
• Study Start: July 1, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share