Clinical trial NCT02800798: Correlation Between Preeclampsia and Positive for Obstructive Sleep Apnea Screening Test: STOPBANG Questionnaire
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sleep Apnea, Obstructive
Keywords: Obstructive sleep apnea
Preeclampsia
Pregnancy
Stopbang
Lead sponsor: Ramathibodi Hospital
Sponsor class: OTHER
First posted: 2016-06-15
Enrollment: 1100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Thai pregnant women who were scheduled for cesarean delivery or vaginal delivery at 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.

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of pre-eclampsia between high and low risk of OSA patient based on Stop-bang screening test
timeFrame: 1 day
Secondary outcomes:
measure: prevalence of pre-eclampsia between high and low risk of OSA patient, based on Epworth sleepiness scale
timeFrame: 1 day
measure: prevalence of pre-eclampsia between high and low risk of OSA patient, based on Berlin questionnaire
timeFrame: 1 day
measure: prevalence of pre-eclampsia between high and low risk of OSA patient, based on American society check list
timeFrame: 1 day
measure: The prevalence of maternal adverse event between high risk and low risk of OSA patient
timeFrame: 1 day
measure: The prevalence of neonatal adverse event between high risk and low risk of OSA patient
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
References:
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.
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.
citation: 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.