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

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ClinicalTrials.gov Identifier: NCT02800798
Recruitment Status : Unknown
Verified June 2016 by Lisa Sangkum, Ramathibodi Hospital.
Recruitment status was:  Not yet recruiting
First Posted : June 15, 2016
Last Update Posted : June 16, 2016
Sponsor:
Information provided by (Responsible Party):
Lisa Sangkum, 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

Condition or disease Intervention/treatment
Sleep Apnea, Obstructive Other: Preeclampsia positive

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.

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Study Type : Observational
Estimated Enrollment : 1100 participants
Time Perspective: Cross-Sectional
Study Start Date : June 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Group/Cohort Intervention/treatment
High risk for OSA
High risk OSA defines as Stop-bang score ≥ 3
Other: Preeclampsia positive
Other Name: Preeclampsia negative

Low risk for OSA
Low risk OSA defines as Stop-bang score < 3
Other: Preeclampsia positive
Other Name: Preeclampsia negative




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

Secondary Outcome Measures :
  1. prevalence of pre-eclampsia between high and low risk of OSA patient, based on Epworth sleepiness scale [ Time Frame: 1 day ]
  2. prevalence of pre-eclampsia between high and low risk of OSA patient, based on Berlin questionnaire [ Time Frame: 1 day ]
  3. prevalence of pre-eclampsia between high and low risk of OSA patient, based on American society check list [ Time Frame: 1 day ]
  4. 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

  5. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Thai pregnant women who were scheduled for cesarean delivery or vaginal delivery at Ramathibodi hospital
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02800798


Contacts
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Contact: Lisa Sangkum, MD 6622011513 lisa.sangkum@gmail.com

Sponsors and Collaborators
Ramathibodi Hospital
Publications:
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Responsible Party: Lisa Sangkum, Doctor, Ramathibodi Hospital
ClinicalTrials.gov Identifier: NCT02800798    
Other Study ID Numbers: Ramathibodi
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: June 16, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Lisa Sangkum, Ramathibodi Hospital:
Obstructive sleep apnea
Preeclampsia
Pregnancy
Stopbang
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Pre-Eclampsia
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Hypertension, Pregnancy-Induced
Pregnancy Complications