The Effect of OSA on Pregnancy and Fetal Outcomes

Pregnancy Clinical Trial

Official title:

The Effect of Obstructive Sleep Apnea on Pregnancy and Fetal Outcomes

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06391138
• Other study ID #: PKUFH ENT OSAP V1.0
• Status: Not yet recruiting
• Start date: July 15, 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
• Study type: Observational

Clinical Trial 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.

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 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.

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Pregnancy
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Continuous Positive Airway Pressure
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.

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	birth weight	birth weight of newborns measured in grams	10 months
Other	length of newborns	length of newborns measured in centimeters	10 months
Other	The 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	rate of pre-eclampsia/ eclampsia		10 months
Secondary	rate of preterm birth		10 months