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Screening and Treatment of Obstructive Sleep Apnea in High-risk Pregnancy

NCT03356106 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 340

Last updated 2021-12-07

No results posted yet for this study

Summary

This is an open-label multicenter randomized-controlled trial in 3 tertiary care hospitals including Ramathibodi Hospital, Phramongkutklao Hospital and Rajavithi Hospital. The study involved screening of obstructive sleep apnea in high risk pregnancy during 1st and 2nd trimesters. Randomization to either continuous positive airway pressure (CPAP) or usual antenatal care (ANC) until delivery will be done. Efficacy of CPAP on pregnancy outcome will be analysed.

Conditions

  • Sleep Apnea, Obstructive
  • Pre-Eclampsia
  • Hypertension, Pregnancy-Induced

Interventions

DEVICE

Continuous positive airway pressure (CPAP)

A non-invasive positive pressure device that is used for the treatment of obstructive sleep apnea by splinting the collapsed upper airway during sleep

Sponsors & Collaborators

  • National Research Council of Thailand

    collaborator OTHER_GOV

  • Ramathibodi Hospital

    lead OTHER

Principal Investigators

  • Visasiri Tantrakul, MD · Ramathibodi Hospital Sleep Disorder Center, Pulmonary and Care division, Department of Medicine, Ramatibodi Hospital, Mahidol University, Thailand

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-16
Primary Completion
2019-11-30
Completion
2019-12-31

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03356106 on ClinicalTrials.gov