The Effect of CPAP on Maternal and Infant Outcomes in Pregnant Women With OSAS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

108 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-01

Study Completion Date

2026-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this clinical trial is to learn about the impact of CPAP on the maternal and infant outcomes of women with obstructive sleep apnea syndrome. The main questions aim to answer are:

\[question 1\]Explore the impact of different CPAP treatment times on the maternal and infant outcomes of pregnant women with combined OSAS; \[question 2\]Explore the effects of CPAP on placental weight and birth weight/placental weight ratio in OSAS pregnant women.

The CPAP treatment group received standardized CPAP treatment and routine prenatal care, while the non CPAP treatment group and non OSAS group only received routine prenatal care.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Effect of OSA on Pregnancy and Fetal Outcomes

NCT06391138

Pregnancy Obstructive Sleep Apnea

NOT_YET_RECRUITING

Sleep Disordered Breathing, Obesity and Pregnancy Study (SOAP)

NCT02086448

Obese Pregnancy Sleep Disordered Breathing

COMPLETED NA

CPAP in Preeclampsia

NCT02303834

Preeclampsia Hypertension

TERMINATED NA

Continuous Positive Airway Pressure (CPAP) for Sleep Apnea in Pregnancy

NCT03487185

Obstructive Sleep Apnea of Adult Preeclampsia Obstetrical Complications

RECRUITING NA

Positive Airway Pressure Treatment of Obstructive Sleep-disordered Breathing in Hypertensive Disorders of Pregnancy

NCT03309826

Hypertensive Disorder of Pregnancy Sleep Apnea, Obstructive

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Selecting high-risk OSAS pregnant women who underwent sleep breathing monitoring at 24-28 weeks of pregnancy and were registered in the Obstetrics and Gynecology Department of Peking University People's Hospital from January 2024 to December 2025 as the study subjects, collecting baseline data, following up on the study subjects until delivery, collecting CPAP treatment time, maternal and infant outcome related indicators, and placental weight. Assessing high-risk factors for OSAS during prenatal checkups for pregnant women: symptoms, signs, clue diseases, Epworth scale; Select pregnant women who meet the high-risk factors for OSAS at 24-28 weeks and collect their baseline data and ESS scores; Sleep breathing tests were performed on high-risk OSAS pregnant women aged 24-28 weeks, and their AHI, ODI, and SaO2 were recorded; Set AHI ≥ 5 times/h as the OSAS group, with those receiving standard CPAP treatment being the CPAP treatment group, those refusing CPAP treatment being the non CPAP treatment group, and AHI\<5 times/h as the non OSAS group. The CPAP treatment group received standardized CPAP treatment and routine prenatal care, while the non CPAP treatment group and non OSAS group only received routine prenatal care; Follow up the above research subjects until the end of delivery, collect their ESS scores, CPAP treatment time, maternal and infant outcome indicators, and placental weight after treatment. After trimming the fetal membrane and umbilical cord, weigh and measure the placenta. Use statistical methods to analyze baseline data and ESS scores before and after delivery; Analyze the outcomes of pregnant women in different CPAP treatment and control groups, including delivery methods, postpartum hemorrhage, and admission to the intensive care unit (ICU); The neonatal outcomes include gestational age, preterm birth, birth weight of the newborn, infants under gestational age, and umbilical artery blood gas analysis (pH\<7.10, LAC\>=6.0mmol/L, BE\<-12mmol/L); Analyze the placental weight and birth weight/placental weight ratio in the CPAP treatment group, control group, and non OSAS group.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Maternal Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

The CPAP treatment group

CPAP standardized treatment+standard obstetric care

CPAP

Intervention Type DEVICE

70% of nights use CPAP for more than 4 hours

OSAS control group

standard obstetric care

No interventions assigned to this group

Non OSAS group

standard obstetric care

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CPAP

70% of nights use CPAP for more than 4 hours

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* (1)Pregnant women at 24-28 weeks of gestation
* (2)Apnea hypopnea index (AHI) AHI ≥ 5 times/h

Exclusion Criteria

* (1)Multiple pregnancies or fetal malformations
* (2)Severe mental illness
* (3)Severe heart and lung disease or liver and kidney disease
* (4)Previous diagnosis of OSAS
* (5)Other sleep disorders

Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes