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The Effect of OSA on Pregnancy and Fetal Outcomes

The Effect of Obstructive Sleep Apnea on Pregnancy and Fetal Outcomes

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06391138
Enrollment
500
Registered
2024-04-30
Start date
2024-07-15
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

Obstructive Sleep Apnea, Pregnancy

Brief 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.

Interventions

DEVICEContinuous 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.

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 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
rate of pre-eclampsia/ eclampsia10 months

Secondary

MeasureTime frame
rate of preterm birth10 months

Other

MeasureTime frameDescription
birth weight10 monthsbirth weight of newborns measured in grams
length of newborns10 monthslength of newborns measured in centimeters
The 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