The Effect of OSA on Pregnancy and Fetal Outcomes

NCT06391138 | Not Yet Recruiting

• 1 other identifier: PKUFH ENT OSAP V1.0
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pregnancy; Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• rate of pre-eclampsia/ eclampsia

  10 months

Secondary Outcomes (1)

• rate of preterm birth

  10 months

Other Outcomes (3)

• birth weight

  10 months

• length of newborns

  10 months

• The Apgar score of newborns

  10 months

Interventions

Continuous Positive Airway Pressure DEVICE

The intervention in this study involves the use of Continuous Positive Airway Pressure (CPAP) treatment. CPAP is a commonly used therapy for obstructive sleep apnea (OSA) and other sleep-related breathing disorders. The principle of CPAP treatment lies in maintaining a constant airway pressure during sleep to prevent the collapse of the upper airway and ensure unobstructed breathing. The patient wears a mask connected to a CPAP machine, which generates a steady stream of air to provide the necessary pressure.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: pregnancy
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women with OSA who have established prenatal care records and undergone antenatal check-ups at PKUFH

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University First Hospital: lead

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Xiaowan Du

  Peking University First Hospital

  STUDY DIRECTOR

Central Study Contacts

Xiaowan Du

CONTACT

13552834319; xiaowandu26@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: April 30, 2024
• Study Start: July 15, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 4, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share