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

Sleep Apnea, Obstructive Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02800798
• Other study ID #: Ramathibodi
• Status: Not yet recruiting
• Phase: N/A
• First received: June 10, 2016
• Last updated: June 14, 2016
• Start date: June 2016
• Est. completion date: June 2018

Study information

• Verified date: June 2016
• Source: Ramathibodi Hospital
• Contact: Lisa Sangkum, MD
• Phone: 6622011513
• Email: lisa.sangkum[@]gmail.com
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1100
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Other:
• Preeclampsia positive

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ramathibodi Hospital

References & Publications (3)

Antony KM, Agrawal A, Arndt ME, Murphy AM, Alapat PM, Guntupalli KK, Aagaard KM. Association of adverse perinatal outcomes with screening measures of obstructive sleep apnea. J Perinatol. 2014 Jun;34(6):441-8. doi: 10.1038/jp.2014.25. Epub 2014 Mar 6. — View Citation

Chung F, Yegneswaran B, Liao P, Chung SA, Vairavanathan S, Islam S, Khajehdehi A, Shapiro CM. STOP questionnaire: a tool to screen patients for obstructive sleep apnea. Anesthesiology. 2008 May;108(5):812-21. doi: 10.1097/ALN.0b013e31816d83e4. — View Citation

Pengo MF, Rossi GP, Steier J. Obstructive sleep apnea, gestational hypertension and preeclampsia: a review of the literature. Curr Opin Pulm Med. 2014 Nov;20(6):588-94. doi: 10.1097/MCP.0000000000000097. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of pre-eclampsia between high and low risk of OSA patient based on Stop-bang screening test		1 day	No
Secondary	prevalence of pre-eclampsia between high and low risk of OSA patient, based on Epworth sleepiness scale		1 day	No
Secondary	prevalence of pre-eclampsia between high and low risk of OSA patient, based on Berlin questionnaire		1 day	No
Secondary	prevalence of pre-eclampsia between high and low risk of OSA patient, based on American society check list		1 day	No
Secondary	The prevalence of maternal adverse event between high risk and low risk of OSA patient	Maternal adverse events include hypoxemia, arrythmia, perioperative myocardial infarction, heart failure	1 day	No
Secondary	The prevalence of neonatal adverse event between high risk and low risk of OSA patient	Neonatal adverse events include IUGR, neonatal intensive care unit admission, low apgar score	1 day	No