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Effect of OSA Resulting From Chronic Tonsillitis on Pregnancy Outcomes

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06391151
Enrollment
500
Registered
2024-04-30
Start date
2024-07-01
Completion date
2026-06-30
Last updated
2024-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Tonsillitis, Obstructive Sleep Apnea, Pregnancy

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.

Interventions

OTHERexposure: OSA resulting from chronic tonsillitis

exposure: OSA resulting from chronic tonsillitis

Sponsors

Peking University First Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
preterm birth rate10 months

Secondary

MeasureTime frame
delivery methods10 months

Other

MeasureTime frameDescription
pregnancy complications10 months
neonatal birth weight10 monthsbirth weight of newborns measured in grams
neonatal length10 monthslength of newborns measured in centimeters
Apgar score of newborns10 monthsThe 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.

Contacts

Primary ContactXiaowan Du
xiaowandu26@126.com13552834319

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026