PregnancyNCT06391138
The Effect of OSA on Pregnancy and Fetal Outcomes
An observational study of Pregnancy and Obstructive Sleep Apnea, run by Peking University First Hospital.
Trial summary
This cohort study aims to investigate the impact of obstructive sleep apnea hypopnea syndrome (OSA) on pregnancy and fetal outcomes. The hypothesis posits that OSA may aggravate pregnancy complications, elevate the risk of adverse pregnancy outcomes, and potentially impact fetal development. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy, Obstructive Sleep Apnea
- What is being tested?
- Continuous Positive Airway Pressure
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2024to 30 Jun 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant women with OSA who have established prenatal care records and undergone antenatal check-ups at PKUFH
Who may be able to join
- Pregnant women with a confirmed diagnosis of OSA based on polysomnography or other validated sleep monitoring techniques.
- Pregnant women who are willing to participate in the study and provide informed consent.
Who cannot join
- Pregnant women with other respiratory or sleep disorders that may confound the diagnosis of OSA.
- Pregnant women with severe comorbidities or medical conditions that may significantly impact pregnancy outcomes.
- Pregnant women who have undergone surgical treatment for chronic tonsillitis or OSA during the study period.
- Pregnant women who refuse to participate in the study or are unable to provide informed consent.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Obstructive Sleep Apnea on Pregnancy and Fetal Outcomes
This cohort study aims to investigate the impact of obstructive sleep apnea hypopnea syndrome (OSA) on pregnancy and fetal outcomes. The hypothesis posits that OSA may aggravate pregnancy complications, elevate the risk of adverse pregnancy outcomes, and potentially impact fetal development.
- Conditions
- Pregnancy, Obstructive Sleep Apnea
- Being tested
- Continuous Positive Airway Pressure
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Positive Airway PressureDevice
The intervention in this study involves the use of Continuous Positive Airway Pressure (CPAP) treatment. CPAP is a commonly used therapy for obstructive sleep apnea (OSA) and other sleep-related breathing disorders. The principle of CPAP treatment lies in maintaining a constant airway pressure during sleep to prevent the collapse of the upper airway and ensure unobstructed breathing. The patient wears a mask connected to a CPAP machine, which generates a steady stream of air to provide the necessary pressure.
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of pre-eclampsia/ eclampsia
Measured: 10 months
Secondary outcomes (1)
rate of preterm birth
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start15 Jul 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Peking University First 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaowan Du, Peking University First Hospital
- Investigators
- Xiaowan Du, Study director, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06391138
- Sponsor's protocol ID
- PKUFH ENT OSAP V1.0
- Status last verified
- Jun 2024
- First submitted
- 25 Apr 2024
- Last updated
- 4 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will be provided upon request.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Obstructive Sleep Apnea on Pregnancy and Fetal Outcomes
- ClinicalTrials.gov ID
- NCT06391138
- Acronym / sponsor ID
- PKUFH ENT OSAP V1.0
- Conditions
- Pregnancy, Obstructive Sleep Apnea
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 15 Jul 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 30 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.
This cohort study aims to investigate the impact of obstructive sleep apnea hypopnea syndrome (OSA) on pregnancy and fetal outcomes. The hypothesis posits that OSA may aggravate pregnancy complications, elevate the risk of adverse pregnancy outcomes, and potentially impact fetal development.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women with OSA who have established prenatal care records and undergone antenatal check-ups at PKUFH
Key inclusion criteria (2 listed)
- Pregnant women with a confirmed diagnosis of OSA based on polysomnography or other validated sleep monitoring techniques.
- Pregnant women who are willing to participate in the study and provide informed consent.
Key exclusion criteria (4 listed)
- Pregnant women with other respiratory or sleep disorders that may confound the diagnosis of OSA.
- Pregnant women with severe comorbidities or medical conditions that may significantly impact pregnancy outcomes.
- Pregnant women who have undergone surgical treatment for chronic tonsillitis or OSA during the study period.
- Pregnant women who refuse to participate in the study or are unable to provide informed consent.
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 |
|---|---|---|
| Continuous Positive Airway PressureThe intervention in this study involves the use of Continuous Positive Airway Pressure (CPAP) treatment. CPAP is a commonly used therapy for obstructive sleep apnea (OSA) and other sleep-related breathing disorders. The principle of CPAP treatment lies in maintaining a constant airway pressure during sleep to prevent the collapse of the upper airway and ensure unobstructed breathing. The patient wears a mask connected to a CPAP machine, which generates a steady stream of air to provide the necessary pressure. | Device | – |
Primary outcome
rate of pre-eclampsia/ eclampsia
Time frame: 10 months
1 secondary outcome
rate of preterm birth
Time frame: 10 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Individual participant dataSharing planned: No. Individual participant data will be provided upon request.
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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.
Xiaowan Du study director
Peking University First Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy and Obstructive Sleep Apnea, run by Peking University First 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 4 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 4 Jun 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?
Contact Xiaowan Du (13552834319, xiaowandu26@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of pre-eclampsia/ eclampsia (time frame: 10 months). 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 4 Jun 2024.