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

The Effect of Continuous Positive Airway Pressure Ventilation on Maternal and Infant Outcomes in Pregnant Women With Obstructive Sleep Apnea Syndrome

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Maternal Hypertension
• Intervention / Treatment: Device: CPAP

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 108

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

The CPAP treatment group received CPAP standard treatment+standard obstetric care, while the OSAS control group and non OSAS group only received standard obstetric care. The effects of the two different treatment plans were observed.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
The CPAP treatment group; CPAP standardized treatment+standard obstetric care	Device: CPAP; 70% of nights use CPAP for more than 4 hours
OSAS control group; standard obstetric care
Non OSAS group; standard obstetric care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Explore the effects of CPAP on placental weight and birth weight/placental weight ratio in OSAS pregnant women.	Analyze the placental weight and birth weight/placental weight ratio in the CPAP treatment group, control group, and non OSAS group.	April 1, 2024 to December 31, 2025

Collaborators and Investigators

• Sponsor: Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: March 17, 2024
• First Submitted That Met QC Criteria: April 2, 2024
• First Posted (Actual): April 3, 2024

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 20, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: gestational hypertension
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 2024PHB065-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No