NCT03356106

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 340 (actual)
• Sponsor: Ramathibodi Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-11-16
• Primary completion: 2019-11-30
• Completion: 2019-12-31
• First posted: 2017-11-29
• Last updated: 2021-12-07

Locations

3 sites across 1 country: Thailand