Effect of OSA Resulting From Chronic Tonsillitis on Pregnancy Outcomes

April 30, 2024 updated by: Xiaowan Du, Peking University First Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
preterm birth rate
Time Frame: 10 months
10 months

Secondary Outcome Measures

Outcome Measure
Time Frame
delivery methods
Time Frame: 10 months
10 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
pregnancy complications
Time Frame: 10 months
10 months
neonatal birth weight
Time Frame: 10 months
birth weight of newborns measured in grams
10 months
neonatal length
Time Frame: 10 months
length of newborns measured in centimeters
10 months
Apgar score of newborns
Time Frame: 10 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University First Hospital

Investigators

  • Study Director: Xiaowan Du, Peking University First Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 15, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

April 24, 2024

First Submitted That Met QC Criteria

April 25, 2024

First Posted (Actual)

April 30, 2024

Study Record Updates

Last Update Posted (Actual)

May 2, 2024

Last Update Submitted That Met QC Criteria

April 30, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PKUFH ENT TLP V1.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will be provided upon request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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