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

Pregnancy Related Clinical Trial

— SAOSPRONOS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05725642
• Other study ID #: 2022-A00981-42
• Status: Not yet recruiting
• Start date: July 1, 2024
• Est. completion date: November 30, 2026

Study information

• Verified date: April 2024
• Source: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Contact: Anne-Hélène GIRAUD, MD
• Phone: + 33 9 81 60 86 90
• Email: annehelenegiraud[@]yahoo.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: November 30, 2026
• Est. primary completion date: November 30, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy Related
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Other:
• Polysomnography
Polysomnography

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OSAS Diagnosis with polysomnography	Diagnosis of OSAS with polysomnography, prior to the study, or during the first 2 trimesters of pregnancy	9 months