The Effect of OSA on Pregnancy and Fetal Outcomes | NCT06391138

Studies
The Effect of OSA on Pregnancy and Fetal Outcomes

NCT06391138

Sponsor

Peking University First Hospital

Status

Unknown status

Last Update Posted

Jun 4, 2024Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Pregnancy
Obstructive Sleep Apnea

Interventions

Continuous Positive Airway Pressure

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 15, 2024Estimated

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Jun 30, 2026Estimated

First Submitted Date

Apr 25, 2024

First Submission Date that Met QC Criteria

Apr 25, 2024

First Posted Date

Apr 30, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 3, 2024

Last Update Posted Date

Jun 4, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Xiaowan Du, Principal Investigator, Peking University First HospitalPrincipal Investigator

Lead Sponsor

Peking University First HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Continuous Positive Airway Pressure	Device	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
rate of pre-eclampsia/ eclampsia		10 months

Secondary Outcomes

Measure	Description	Time Frame
rate of preterm birth		10 months

Other Outcomes

Measure	Description	Time Frame
birth weight	birth weight of newborns measured in grams	10 months
length of newborns	length of newborns measured in centimeters	10 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

pregnancy

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Pregnant women with OSA who have established prenatal care records and undergone antenatal check-ups at PKUFH

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xiaowan Du	Contact	13552834319		xiaowandu26@126.com

Overall Officials

Name	Affiliation	Role
Xiaowan Du	Peking University First Hospital	Study Director

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Individual participant data will be provided upon request.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020181	Sleep Apnea, Obstructive

Ancestor Terms

ID	Term
D012891	Sleep Apnea Syndromes
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D045422	Continuous Positive Airway Pressure

Ancestor Terms

ID	Term
D011175	Positive-Pressure Respiration
D012121	Respiration, Artificial
D058109	Airway Management
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided