Correlation Between Preeclampsia and Positive for Obstructive Sleep Apnea Screening Test: STOPBANG Questionnaire

June 14, 2016 updated by: Lisa Sangkum, Ramathibodi Hospital
The purpose of this study is to find the correlation between high risk OSA (obstructive sleep apnea) patient, based on Stop-bang screening tool and preeclampsia

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Obstructive sleep apnea (OSA) has been associated with preeclampsia and intrauterine growth retardation (IUGR).

Since the gold standard diagnosis of OSA is polysomnogram which is limited by cost and availability. Therefore, various screening tools were proposed in order to identify high risk OSA patient such as Stop-bang questionnaire.

From the previous study, Stop-bang showed a high predictive performance and the score equal or higher than 3 determines high risk for OSA.

Study Type

Observational

Enrollment (Anticipated)

1100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Thai pregnant women who were scheduled for cesarean delivery or vaginal delivery at Ramathibodi hospital

Description

Inclusion Criteria:

- Pregnant women who were scheduled for cesarean delivery or admitted to the antepartum unit at Ramathibodi hospital

Exclusion Criteria:

  • Age < 18 year old
  • Previous diagnose OSA
  • Patients who have used continuous positive airway pressure (CPAP) or bi-level positive airway pressure (Bi-PAP) fro OSA treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
High risk for OSA
High risk OSA defines as Stop-bang score ≥ 3
Other: Preeclampsia positive
Other Names:
  • Preeclampsia negative
Low risk for OSA
Low risk OSA defines as Stop-bang score < 3
Other: Preeclampsia positive
Other Names:
  • Preeclampsia negative

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevalence of pre-eclampsia between high and low risk of OSA patient based on Stop-bang screening test
Time Frame: 1 day
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
prevalence of pre-eclampsia between high and low risk of OSA patient, based on Epworth sleepiness scale
Time Frame: 1 day
1 day
prevalence of pre-eclampsia between high and low risk of OSA patient, based on Berlin questionnaire
Time Frame: 1 day
1 day
prevalence of pre-eclampsia between high and low risk of OSA patient, based on American society check list
Time Frame: 1 day
1 day
The prevalence of maternal adverse event between high risk and low risk of OSA patient
Time Frame: 1 day
Maternal adverse events include hypoxemia, arrythmia, perioperative myocardial infarction, heart failure
1 day
The prevalence of neonatal adverse event between high risk and low risk of OSA patient
Time Frame: 1 day
Neonatal adverse events include IUGR, neonatal intensive care unit admission, low apgar score
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ramathibodi Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

June 1, 2018

Study Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

June 10, 2016

First Submitted That Met QC Criteria

June 10, 2016

First Posted (Estimate)

June 15, 2016

Study Record Updates

Last Update Posted (Estimate)

June 16, 2016

Last Update Submitted That Met QC Criteria

June 14, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ramathibodi

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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