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Not yet recruiting NCT05725642

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

Observational Pregnancy Related

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Polysomnography.
Who it may be relevant to
Registry conditions: Pregnancy Related. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

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.

Interventions

  • Other Polysomnography
    Polysomnography

Primary outcome measures

  • OSAS Diagnosis with polysomnography [Time frame: 9 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT05725642 · 2022-A00981-42

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗