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NCT Number: NCT05725642

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polysomnography

Other

Polysomnography

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Anne-Hélène GIRAUD, MD

CONTACT

[email protected]

+ 33 9 81 60 86 90

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Registry information

Acronym: SAOSPRONOS

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 13, 2023
Registry last updated
Apr 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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