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NCT06391151 Clinical Trial

Effect of OSA Resulting From Chronic Tonsillitis on Pregnancy Outcomes

Pregnancy Clinical Trial

Official title:
Effect of Obstructive Sleep Apnea (OSA) Resulting From Chronic Tonsillitis on Pregnancy Outcomes

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06391151
Other study ID # PKUFH ENT TLP V1.0
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date July 1, 2024
Est. completion date June 30, 2026

Study information
Verified date June 2024
Source Peking University First Hospital
Contact Xiaowan Du
Phone 13552834319
Email xiaowandu26@126.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 500
Est. completion date June 30, 2026
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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. 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

Related Conditions & MeSH terms

Intervention

Other:
• exposure: OSA resulting from chronic tonsillitis
exposure: OSA resulting from chronic tonsillitis

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Peking University First Hospital

Outcome
Type Measure Description Time frame Safety issue
Other pregnancy complications 10 months
Other neonatal birth weight birth weight of newborns measured in grams 10 months
Other neonatal length length of newborns measured in centimeters 10 months
Other Apgar score of newborns The Apgar score consists of five main indicators: skin color, heart rate, response to stimulation, muscle tone, and respiration. Each indicator is scored from 0 to 2, with a total score of 10. This scoring method serves as a guiding tool for the resuscitation of newborns with asphyxia and could provide a degree of predictive value for the neurological development of infants in the future. 10 months
Primary preterm birth rate 10 months
Secondary delivery methods 10 months
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