NCT02800798

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,100

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2016

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

June 10, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 15, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

June 16, 2016

Status Verified

June 1, 2016

Enrollment Period

2 years

First QC Date

June 10, 2016

Last Update Submit

June 14, 2016

Conditions

Keywords

Obstructive sleep apneaPreeclampsiaPregnancyStopbang

Outcome Measures

Primary Outcomes (1)

  • Prevalence of pre-eclampsia between high and low risk of OSA patient based on Stop-bang screening test

    1 day

Secondary Outcomes (5)

  • 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

  • The prevalence of neonatal adverse event between high risk and low risk of OSA patient

    1 day

Study Arms (2)

High risk for OSA

High risk OSA defines as Stop-bang score ≥ 3

Other: Preeclampsia positive

Low risk for OSA

Low risk OSA defines as Stop-bang score \< 3

Other: Preeclampsia positive

Interventions

Also known as: Preeclampsia negative
High risk for OSALow risk for OSA

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 18431116BACKGROUND
  • 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.

    PMID: 25250803BACKGROUND
  • 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.

    PMID: 24603455BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, ObstructivePre-Eclampsia

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesHypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Central Study Contacts

Lisa Sangkum, MD

CONTACT

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

June 10, 2016

First Posted

June 15, 2016

Study Start

June 1, 2016

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

June 16, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share