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Clinical Trials/NCT06391138
NCT06391138
Not yet recruiting
Not Applicable

The Effect of Obstructive Sleep Apnea on Pregnancy and Fetal Outcomes

Peking University First Hospital0 sites500 target enrollmentJuly 15, 2024
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ConditionsPregnancyObstructive Sleep Apnea

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pregnancy
Sponsor
Peking University First Hospital
Enrollment
500
Primary Endpoint
rate of pre-eclampsia/ eclampsia
Status
Not yet recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

This cohort study aims to investigate the impact of obstructive sleep apnea hypopnea syndrome (OSA) on pregnancy and fetal outcomes. The hypothesis posits that OSA may aggravate pregnancy complications, elevate the risk of adverse pregnancy outcomes, and potentially impact fetal development.

Registry
clinicaltrials.gov
Start Date
July 15, 2024
End Date
June 30, 2026
Last Updated
last year
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Xiaowan Du

Principal Investigator

Peking University First Hospital

Eligibility Criteria

Inclusion Criteria

  • •Pregnant women with a confirmed diagnosis of OSA based on polysomnography or other validated sleep monitoring techniques.
  • •Pregnant women who are willing to participate in the study and provide informed consent.

Exclusion Criteria

  • •Pregnant women with other respiratory or sleep disorders that may confound the diagnosis of OSA.
  • •Pregnant women with severe comorbidities or medical conditions that may significantly impact pregnancy outcomes.
  • •Pregnant women who have undergone surgical treatment for chronic tonsillitis or OSA during the study period.
  • •Pregnant women who refuse to participate in the study or are unable to provide informed consent.

Outcomes

Primary Outcomes

rate of pre-eclampsia/ eclampsia

Time Frame: 10 months

Secondary Outcomes

  • rate of preterm birth(10 months)

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