Maternal HypertensionNCT06344702
The Effect of CPAP on Maternal and Infant Outcomes in Pregnant Women With OSAS
An observational study of Maternal Hypertension, run by Peking University People's Hospital.
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… Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal Hypertension
- What is being tested?
- CPAP
- Type of treatment
- Medical device
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to 1 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- (1)Pregnant women at 24-28 weeks of gestation
- (2)Apnea hypopnea index (AHI) AHI ≥ 5 times/h
Who cannot join
- (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
About this study
Official title: 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.
Read the 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.
- Conditions
- Maternal Hypertension
- Being tested
- CPAP
- Keywords
- gestational hypertension
- Medical subject headings
- Hypertension, Pregnancy-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAPDevice
70% of nights use CPAP for more than 4 hours
| Study group | Role | What they receive |
|---|---|---|
| The CPAP treatment group | CPAP standardized treatment+standard obstetric care Receives: Device: CPAP | |
| OSAS control group | standard obstetric care | |
| Non OSAS group | standard obstetric care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: April 1, 2024 to December 31, 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start1 May 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal HypertensionStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guoli Liu, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06344702
- Sponsor's protocol ID
- 2024PHB065-001
- Status last verified
- Apr 2024
- First submitted
- 17 Mar 2024
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Continuous Positive Airway Pressure Ventilation on Maternal and Infant Outcomes in Pregnant Women With Obstructive Sleep Apnea Syndrome
- ClinicalTrials.gov ID
- NCT06344702
- Acronym / sponsor ID
- 2024PHB065-001
- Conditions
- Maternal Hypertension
- Keywords
- gestational hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 3 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The CPAP treatment group | – | Device: CPAPCPAP standardized treatment+standard obstetric care |
| OSAS control group | – | –standard obstetric care |
| Non OSAS group | – | –standard obstetric care |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- (1)Pregnant women at 24-28 weeks of gestation
- (2)Apnea hypopnea index (AHI) AHI ≥ 5 times/h
Key exclusion criteria (5 listed)
- (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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPAP70% of nights use CPAP for more than 4 hours | Device | The CPAP treatment group |
Primary outcome
Explore the effects of CPAP on placental weight and birth weight/placental weight ratio in OSAS pregnant women.
Time frame: April 1, 2024 to December 31, 2025
Analyze the placental weight and birth weight/placental weight ratio in the CPAP treatment group, control group, and non OSAS group.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Maternal Hypertension, run by Peking University People's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Explore the effects of CPAP on placental weight and birth weight/placental weight ratio in OSAS pregnant women. (time frame: April 1, 2024 to December 31, 2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.