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

• Conditions: Sleep Apnea, Obstructive
• Interventions: Other: Preeclampsia positive

• Registration Number: NCT02800798
• Lead Sponsor: Ramathibodi Hospital

Brief Summary

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

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 Timeline

• Status Verified: 2016-06
• Study Start: 2016-06
• Study First Submitted: 2016-06-10
• Study First Submitted QC: 2016-06-10
• Last Update Submitted: 2016-06-14
• Study First Posted: 2016-06-15
• Last Update Posted: 2016-06-16
• Primary Completion: 2018-06
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Low risk for OSA	Preeclampsia positive	Low risk OSA defines as Stop-bang score \< 3
High risk for OSA	Preeclampsia positive	High risk OSA defines as Stop-bang score ≥ 3

Primary Outcome Measures

Name	Time	Method
Prevalence of pre-eclampsia between high and low risk of OSA patient based on Stop-bang screening test	1 day

Secondary Outcome Measures

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