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

NCT06344702 | Not Yet Recruiting DMC

• 1 other identifier: 2024PHB065-001
• Study Type: observational
• Target: 108
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Maternal Hypertension

Keywords

gestational hypertension

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

The CPAP treatment group

CPAP standardized treatment+standard obstetric care

Device: CPAP

OSAS control group

standard obstetric care

Non OSAS group

standard obstetric care

Interventions

CPAP DEVICE

70% of nights use CPAP for more than 4 hours

The CPAP treatment group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• (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

Sponsors & Collaborators

• Peking University People's Hospital: lead

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: March 17, 2024
• First Posted: April 3, 2024
• Study Start: May 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: May 1, 2026
• Last Updated: April 23, 2024

Record last verified: 2024-04