Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06344702 |
| Other study ID # |
2024PHB065-001 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2024 |
| Est. completion date |
May 1, 2026 |
Study information
| Verified date |
April 2024 |
| Source |
Peking University People's Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
