Screening and Treatment of Obstructive Sleep Apnea in High-risk Pregnancy
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Hypertension Pregnancy-induced
- Pre Eclampsia
- Sleep Apnea - Obstructive
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 50 years
- Gender
- Only males
Description
Screening for sleep disordered breathing (Respiratory disturbance index, RDI ? 5 events/hour) with type 2 sleep test will be performed in eligible subjects during early1st trimester (<16 weeks). Repeat sleep study will be done if the RDI in 1st trimester is less than 5. If the subjects meet the incl...
Screening for sleep disordered breathing (Respiratory disturbance index, RDI ? 5 events/hour) with type 2 sleep test will be performed in eligible subjects during early1st trimester (<16 weeks). Repeat sleep study will be done if the RDI in 1st trimester is less than 5. If the subjects meet the inclusion criteria without any of the exclusion criteria, randomization into either receiving CPAP treatment or usual ANC will be done. The pressure of CPAP machine is determined using autoCPAP machine algorithm at 90 percentile. Adjustment of CPAP machine is repeated at 24-28 week gestations. Subjects in both groups received standard usual care during ANC and outcomes were measured with similar case record forms.
Tracking Information
- NCT #
- NCT03356106
- Collaborators
- National Research Council of Thailand
- The Development Potentials of Thai People Project, Ramathibodi hospital
- Investigators
- Principal Investigator: Visasiri Tantrakul, MD Ramathibodi Hospital Sleep Disorder Center, Pulmonary and Care division, Department of Medicine, Ramatibodi Hospital, Mahidol University, Thailand
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