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

Sleep Apnea, Obstructive Clinical Trial

Official title: Screening and Treatment of Obstructive Sleep Apnea in High-risk Pregnancy: A Multi-center Randomized Controlled Trial

Status Completed

Clinical Trial 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.

Clinical Trial 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 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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT03356106
• Study type: Interventional
• Source: Ramathibodi Hospital
• Status: Completed
• Phase: N/A
• Start date: November 16, 2016
• Completion date: December 31, 2019