Effect of OSA Resulting From Chronic Tonsillitis on Pregnancy Outcomes

NCT06391151 | Not Yet Recruiting

• 1 other identifier: PKUFH ENT TLP 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) resulting from chronic tonsillitis on pregnancy outcomes. The hypothesis posits that chronic tonsillitis-induced OSA may exacerbate pregnancy complications and increase the risk of adverse pregnancy outcomes.

Conditions

Obstructive Sleep Apnea; Chronic Tonsillitis; Pregnancy

Outcome Measures

Primary Outcomes (1)

• preterm birth rate

  10 months

Secondary Outcomes (1)

• delivery methods

  10 months

Other Outcomes (4)

• pregnancy complications

  10 months

• neonatal birth weight

  10 months

• neonatal length

  10 months

Interventions

exposure: OSA resulting from chronic tonsillitis OTHER

exposure: OSA resulting from chronic tonsillitis

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 who have established prenatal care records and undergone antenatal check-ups at PKUFH

You may qualify if:

• Pregnant women confirmed with chronic tonsillitis by clinical diagnosis and presenting symptoms.
• 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

Condition Hierarchy (Ancestors)

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

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 24, 2024
• First Posted: April 30, 2024
• Study Start: July 1, 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