Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06344702
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-23
First Post:
2024-03-17
Brief Title:
The Effect of CPAP on Maternal and Infant Outcomes in Pregnant Women With OSAS
Sponsor:
Peking University Peoples Hospital
Organization:
Peking University Peoples Hospital
Study Overview
Official Title:
The Effect of Continuous Positive Airway Pressure Ventilation on Maternal and Infant Outcomes in Pregnant Women With Obstructive Sleep Apnea Syndrome
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 1Explore the impact of different CPAP treatment times on the maternal and infant outcomes of pregnant women with combined OSAS question 2Explore the effects of CPAP on placental weight and birth weightplacental 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
question 1Explore the impact of different CPAP treatment times on the maternal and infant outcomes of pregnant women with combined OSAS question 2Explore the effects of CPAP on placental weight and birth weightplacental 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
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 Peoples 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 timesh 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 AHI5 timesh 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 pH710 LAC60mmolL BE-12mmolL Analyze the placental weight and birth weightplacental weight ratio in the CPAP treatment group control group and non OSAS group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None