Randomized Controlled Trial for a Sleep Study and Targeted CPAP Therapy for Obstructive Sleep Apnea to Reduce the Incidence Adverse Pregnancy Related Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 193
- 试验地点
- 2
- 主要终点
- Number of Participants With Adverse Pregnancy Outcomes
研究概览
简要总结
Prospective, randomized controlled trial. Pregnant women in early pregnancy will be randomized to either the Sleep Study + CPAP (Continuous Positive Airway Pressure Therapy) group or to a Standard Prenatal Care group. Subjects in the Sleep Study + CPAP group will complete a sleep study (WatchPAT-200, Itamar Medical, Inc.) and have CPAP initiated if the Apnea Hypopnea Index (AHI) ≥5 as indicated, in early and late pregnancy, whereas the other group will receive standard prenatal care. All subjects will complete a sleep study again between 8 to 12 weeks postpartum.
详细描述
Objective/Hypothesis: The purpose of this study is to determine if parturients identified as high risk for obstructive sleep apnea (OSA; defined as an apnea hypopnea index [AHI] ≥5 events/hour) who are randomized to receive an unattended sleep study during early and late pregnancy (early = between 6 and 16 weeks; late = between 27 and 33 weeks) plus initiation of CPAP therapy if the AHI ≥5 events/hour and standard prenatal care have a decreased incidence of adverse pregnancy outcomes (defined as a composite variable which includes gestational hypertension, preeclampsia, eclampsia, gestational diabetes, preterm birth, low birth weight, or stillbirth) at the time of delivery when compared to a group who receives standard prenatal care only (no sleep study and CPAP initiation). At 8 to 12 months postpartum subjects in both groups will complete a sleep study.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •At least one of the following risk factors for OSA: prepregnancy BMI ≥ 30kg/m2, chronic hypertension, pregestational diabetes, twin gestation, or a history of prior pregnancy affected by: preeclampsia, eclampsia or fetal growth restriction.
- •Between 6 and 16 weeks gestation at time of enrollment.
排除标准
- •Current diagnosis and treatment of OSA.
- •Patient refusal to randomization.
- •Permanent Pacemaker (interfere with WATCHPAT sleep study).
- •Currently taking alpha blockers or nitrates (interfere with WATCHPAT sleep study).
- •Coronary artery disease or congestive heart failure or cardiomyopathy.
- •Not delivering and completing their postpartum visit at Naval Medical Center San Diego (NMCSD).
- •Inability to read or understand the consent.
- •<18 years of age.
结局指标
主要结局
Number of Participants With Adverse Pregnancy Outcomes
时间窗: time of delivery
Number of participants with adverse pregnancy outcomes (composite outcome includes: gestational hypertension, preeclampsia, eclampsia, gestational diabetes, preterm delivery, low birth weight, or stillbirth)
次要结局
- Hospital Costs at Time of Delivery(Hospital costs at time of delivery)
- Incidence of Obstructive Sleep Apnea (OSA) in Early Pregnancy - Treatment Group Only (6-16 Weeks)(early pregnancy (6-16 weeks))
- Incidence of OSA in Late Pregnancy- Treatment Group Only (27-33 Weeks)(27-33 weeks)
- Incidence of OSA at 8 to 12 Weeks Postpartum in Treatment and Control Group(8-12 weeks postpartum)
研究者
CAPT Dennis Spence, NC, USN, PhD, CRNA
Anesthesia Nurse
United States Naval Medical Center, San Diego