Use of PAP in Women With Pre-eclampsia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 2
- 主要终点
- Severity of Sleep Disordered Breathing
研究概览
简要总结
The purpose of this study is to identify whether sleep-disordered breathing - as measured by overnight polysomnography - is associated with pre-eclampsia and to determine whether use of positive airway pressure can improve nocturnal blood pressure.
详细描述
Initial enrollment began with only women with a pre-existing diagnosis of pre-eclampsia. Part way through the study, IRB granted approval to expand recruitment to include other hypertensive diagnoses. So, in effect, a more accurate post hoc title would be Study of Positive Airway Pressure to Reduce Blood Pressure in Hypertensive Pregnancies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with preeclampsia who receive care at the University of Michigan Hospitals
- •No current use of PAP therapy.
- •Willing and able to provide informed consent.
排除标准
- •Current PAP therapy
- •Any medical reason why PAP therapy may not be suitable (e.g., in patients with recent head trauma).
- •Cognitively impaired and unable to understand informed consent.
研究组 & 干预措施
Positive Airway Pressure (compliant)
This arm was women who used auto-titrating positive airway pressure (APAP) for at least 4 hours per night
干预措施: Positive Airway Pressure (Device)
Standard care
Positive Airway Pressure (non-compliant)
No one was assigned to this arm, but for results data quality purposes, women assigned to PAP who were explicitly non-compliant (used less than 4 hours per night), were analyzed separately from women who were compliant with the PAP assignment.
干预措施: Positive Airway Pressure (Device)
结局指标
主要结局
Severity of Sleep Disordered Breathing
时间窗: at baseline
Severity of sleep disordered breathing, using the apnea/hypopnea index (number of respiratory evens per hour of sleep), among participants who have or do not have nocturnal hypertension. Obstructive sleep apnea is typically considered present if the AHI is at least 5.
Nocturnal Blood Pressure
时间窗: baseline and 1 week after PAP treatment.
measured by a 24 hour cuff, averaged across the night;
Number of Participants With Worsening of Hypertension
时间窗: 1-6 months after enrollment.
This outcome measure's purpose was to look at the impact of the APAP on blood pressure. This was done categorically by looking at worsening of hypertension with or without escalation of antihypertensive medications.
Number of Participants With Sleep-disordered Breathing (SDB)
时间窗: Baseline night 1
Presence or absence of SDB (defined as an apnea/hypopnea index; AHI\>=5)
次要结局
- Gestational Age at Delivery(At delivery (within 6 months of enrollment).)
- NICU Admission(at delivery (within 6 months of enrollment))
- Birth Weight(At delivery (within 6 months of enrollment))
研究者
Louise O'Brien
Associate Professor
University of Michigan