Screening and Treatment of Obstructive Sleep Apnea in High-risk Pregnancy: A Multi-center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 340
- 试验地点
- 6
- 主要终点
- Measurement of blood pressure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Subjects' unwillingness to participate in the study at any time of the study.
- •Subject with significant medical conditions such as immunocompromised status, chronic infection (HIV infection, tuberculosis), chronic lung and cardiac conditions, chronic renal failure, thyroid disease, or neuromuscular disease.
- •Subjects with extremely severe obstructive sleep apnea (RDI ≥30) or with significant O2 desaturation <80% during sleep that might have potential benefit from the CPAP treatment.
- •Subject with known obstructive sleep apnea and currently on CPAP treatment
结局指标
主要结局
Measurement of blood pressure
时间窗: During 18-20 weeks gestation
Difference of daytime mean blood pressure between 2 groups (mmHg)
次要结局
- Neonatal ICU admission rate(Through study completion up to 24 weeks)
- 24-hour ambulatory blood pressure monitoring(measured twice during 32-34 week gestation)
- Incidence of hypertensive disorder of pregnancy or preterm labor or fetal growth restriction or emergency Cesarean section (composite outcome2)(During pregnancy until delivery)
- Incidence of preterm labor or fetal growth restriction or severe pre-eclampsia or eclampsia or death (composite outcome3)(During pregnancy until delivery)
- Fasting plasma glucose(during 32-34 weeks gestation)
- Oral glucose tolerance test (OGTT)(during 24-28 weeks gestation)
- Incidence of pregnancy induced hypertension (composite outcome1)(During pregnancy until delivery)
- Neonatal length of stay in hospital(Through study completion up to 24 weeks)
- Neonatal birthweight(at delivery)
- APGAR score(at 1 minute and 5 minutes after birth)
- Fetal ultrasound results(During 32-34 weeks gestation)
研究者
Visasiri Tantrakul
Dr.
Ramathibodi Hospital