The Effect of OSA on Pregnancy and Fetal Outcomes

Not yet recruiting

• Conditions: Pregnancy; Obstructive Sleep Apnea

• Registration Number: NCT06391138
• Lead Sponsor: Peking University First Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-25
• Study First Submitted QC: 2024-04-25
• Study First Posted: 2024-04-30
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-03
• Last Update Posted: 2024-06-04
• Study Start: 2024-07-15
• Primary Completion: 2025-12-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
rate of pre-eclampsia/ eclampsia	10 months

Secondary Outcome Measures

Name	Time	Method
rate of preterm birth	10 months