A Randomized Trial of Continuous Positive Airway Pressure (CPAP) for Sleep Apnea in Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,500
- 试验地点
- 23
- 主要终点
- Diagnosis of Hypertensive Disorders of Pregnancy
研究概览
简要总结
A randomized controlled trial of 1,500 women to assess whether treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP) in pregnancy will result in a reduction in the rate of hypertensive disorders of pregnancy.
详细描述
Emerging data support a link between sleep disordered breathing (SDB) and adverse pregnancy outcomes. In particular, women with obstructive sleep apnea (OSA) appear to be at increased risk of both hypertensive disorders of pregnancy and gestational diabetes. In the non-pregnant population, OSA is typically treated with continuous positive airway pressure (CPAP) during sleep and has been shown to reduce blood pressure in hypertensive patients. Unfortunately, data on whether maternal and neonatal outcomes could be improved with treatment of OSA during pregnancy are extremely limited. This study aims to address this knowledge gap.
A randomized controlled trial of 1,500 women to assess whether treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP) in pregnancy will result in a reduction in the rate of hypertensive disorders of pregnancy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
This study is an unmasked randomized controlled multi-center clinical trial.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Singleton gestation. Twin gestation reduced to singleton, either spontaneously or therapeutically, is not eligible unless the reduction occurred before 14 weeks project gestational age.
- •Gestational age at randomization between 14 weeks 0 days and 21 weeks 6 days based on clinical information and evaluation of the earliest ultrasound.
- •Diagnosis with mild to moderate OSA as defined by an AHI score ≥ 5 and <30.
排除标准
- •Previously prescribed, current or planned therapy for sleep apnea.
- •Age < 18 years, because the rate of sleep apnea in this population is extremely low.
- •Inability to sleep in a stable place with access to the CPAP machine at least 5 nights per week.
- •Asthma requiring systemic steroid therapy for more than 14 days within the past 6 months because this population is expected to be unresponsive to CPAP therapy.
- •Current use of prescribed sleeping pills for insomnia.
- •Chronic medical conditions requiring oxygen supplementation (e.g. pulmonary fibrosis, pulmonary hypertension, cystic fibrosis) because this population is expected to be unresponsive to CPAP therapy.
- •Chronic renal disease with serum creatinine >1.3 mg/dL because the primary outcome would be pre-determined.
- •Antiphospholipid antibody syndrome, because it would compromise the primary outcome diagnosis.
- •History of medical complications such as:
- •Active liver disease (acute hepatitis, chronic active hepatitis, persistently abnormal liver enzymes)
- •Thrombocytopenia with platelet count <100,000 because of the difficulty in assessing the primary outcome.
- •Active vaginal bleeding (more than spotting) at the time of randomization.
- •Known chromosomal, genetic, major malformations or fetal demise, or planned termination of pregnancy because inclusion would compromise evaluation of secondary neonatal outcomes.
- •Known major uterine malformations associated with adverse pregnancy outcomes.
- •Current use of opiates (heroin, methadone, or other daily opioid use) due to inaccuracy of the home sleep test and inefficiency of CPAP.
- •Active drug use, alcohol use, or unstable psychiatric condition.
- •Participation in another interventional study that influences preeclampsia, hypertensive disorders of pregnancy, or GDM.
- •Prenatal care or delivery planned at a non-network center where access to the complete electronic medical record will not be available to research staff.
- •Participation in this trial in a previous pregnancy. Patients who were screened in a previous pregnancy, but not randomized, may be included.
研究组 & 干预措施
Sleep Advice Control
Initial sleep advice counseling alone
干预措施: Sleep Advice Control (Other)
Continuous Positive Airway Pressure
Autotitrating CPAP with weekly contact, incentives for compliance and initial sleep advice counseling
干预措施: Continuous Positive Airway Pressure (Device)
结局指标
主要结局
Diagnosis of Hypertensive Disorders of Pregnancy
时间窗: Up to 14 days postpartum
Subjects are considered to have the primary outcome if they meet the criteria for eclampsia, HELLP, atypical HELLP, preeclampsia, superimposed preeclampsia or antepartum gestational hypertension.
次要结局
- Preterm birth(Preterm delivery up to and less than 37 weeks gestation)
- Cesarean Delivery(At the time of delivery)
- Maternal morbidity composite(Within 6 weeks postpartum)
- Birth weight(Immediately post birth)
- Fetal or Neonatal Death(through 72 hours postpartum)
- Neonatal encephalopathy(within 72 hours of delivery)
- Gestational diabetes(As soon as possible after randomization between 14 weeks, 0 days and 21 weeks, 6 days gestation)
- Maternal adverse cardiovascular outcome composite(By 6 weeks postpartum)
- Neonatal respiratory support(within 72 hours of delivery)
- Neonatal Seizures(72 hours post birth)
- Shoulder dystocia(During delivery)
- Birth trauma(During delivery)
- Intracranial hemorrhage(Within 72 hours post delivery)
- Hyperbilirubinemia(Within 72 hours post delivery)
- Hypoglycemia(Within 72 hours post delivery)
- NICU Stay(Greater than or equal to 72 hours post birth)