Placental Role in Mediating Adverse Outcomes in Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 262
- 试验地点
- 2
- 主要终点
- Alterations in circulating placenta-secreted markers.
研究概览
简要总结
This study is testing the hypothesis of whether continuous positive airway pressure (CPAP) therapy improves placental histopathology and secretory function. The main aims of the study are to identify shared mechanisms between obstructive sleep apnea and preeclampsia, both common highly morbid conditions.
详细描述
Patients will be recruited from multiple community and hospital-based practices that care for pregnant women. Subjects will be given a physical exam, have measurements taken, answer questionnaires and then will be screened using a home sleep apnea test (HSAT) Type III device. Those diagnosed with Obstructive Sleep Apnea will then be randomized to one of two groups (below).
Both groups will have:
- blood testing for placenta-secreted circulating markers
- placental histopathological and immunohistochemistry examination of placental expression of markers.
Both groups will answer sleep and mood questionnaires, have blood pressure, blood glucose and activity / sleep watch monitoring and will receive an educational session on pregnancy health.
Randomization groups include:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
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
- •Pregnant snorers without obstructive sleep apnea, have a BMI >30 kg/m2 at recruitment
- •>18 years of age
- •<13 completed weeks of gestation (confirmed by last menstrual period or early pregnancy dating ultrasound during qualification)
- •Intention to reside locally and deliver at Women and Infants Hospital of Rhode Island
- •Ability to give informed consent.
排除标准
- •Unable to meet inclusion criteria, Incompetent cervix / cerclage (likelihood of severe preterm delivery affecting study aims)
- •Inability to tolerate PAP therapy
- •Serious physical or mental illness or condition that would affect participation
- •Drowsy driving
- •Severe hypoxemia on sleep study
- •Advanced cardiac disease or arrhythmias that may benefit from PAP therapy
- •Chronic lung disease and / or respiratory failure.
- •Twin pregnancies
- •Fetuses with congenital anomalies
- •Severe hypertension at enrollment
研究组 & 干预措施
Nasal Dilator Strips
Nasal dilator strips during sleep.
干预措施: Nasal Dilator Strips (Other)
Positive Airway Pressure
Positive airway pressure and nasal dilator strips during sleep.
干预措施: Positive Airway Pressure (Device)
Positive Airway Pressure
Positive airway pressure and nasal dilator strips during sleep.
干预措施: Nasal Dilator Strips (Other)
结局指标
主要结局
Alterations in circulating placenta-secreted markers.
时间窗: up to 6 months
Placenta secreted markers that have been linked to preeclampsia as well as angiogenic and anti-angiogenic markers will be measured longitudinally during the course of pregnancy.
Changes in placental histopathology for markers of malperfusion and placental expression of markers
时间窗: Placenta collected at time of delivery
Placental morphology and histopathology will be examined by 3 perinatal pathologists, blinded to each other's reading and to intervention arm. Immunohistochemistry will be used to examine placental expression of certain markers.
次要结局
- Change in a composite of adverse pregnancy outcomes(8 months, delivery and 2 weeks postpartum)
- Change in 24-hour Ambulatory mean diurnal and nocturnal blood pressure measurements(Prior to randomization, then at approximately 3 months, and 6 months later)