Single Blinded Randomised Control Trial of Treatment of Sleep Disordered Breathing in Preeclampsia With Nasal CPAP
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 4
- 主要终点
- Fetal movements
研究概览
简要总结
Study design:
Single blinded randomised control trial
Planned sample size:
30 (women randomized 2:1 to receive either CPAP or no CPAP)
Objectives:
Primary objective: Assess the effects of nasal CPAP on sleep physiology, 24 blood pressures and fetal movements in pregnant women (24-37 weeks gestation) with preeclampsia.
Secondary objective: Assess baseline sleep physiology, blood pressure control and fetal well-being in pregnant women (24-37 weeks gestation) with preeclampsia by completing sleep studies, 24 hour blood pressure monitors, CO2 monitors, and nocturnal fetal movement and HR monitors.
Study Procedure:
Participants will be recruited from the antenatal ward or high-risk antenatal clinic. Following informed consent participants will be randomly assigned to receive either CPAP or no CPAP for one night, following an initial baseline overnight sleep study.
Baseline- Night 1
- Sleep study with fetal movement and HR monitor
- 24 hour BP monitor
- CO2 monitor
Intervention- Night 2 (Nasal CPAP device or no CPAP)
- Sleep study with fetal movement and HR monitor
- 24 hour BP monitor
- CO2 monitor
Post-partum questionnaire A brief questionnaire to be completed within the first 6 weeks post-partum related to the participant's personal health, their child's birth details and health.
详细描述
DESIGN Single blinded randomized control trial STUDY GROUPS Women diagnosed with preeclampsia by their treating physicians (BP>140/90 and proteinuria> 300mg in 24 hours) who are being managed either as inpatients or out-patients. They will be randomized in a 2:1 ratio to receive active CPAP or no CPAP either in hospital (if they are inpatients) or at home (outpatients).
NUMBER OF PARTICIPANTS A total of 30 women will be recruited. NUMBER OF CENTRES This study will be conducted at 2 centres- Royal Hospital for Women, Randwick and Royal Prince Alfred Hospital, Camperdown. The aim will be to recruit 15 participants from each site.
INTERVENTIONS The intervention is nasal CPAP. The intervention group will be fitted with nasal CPAP on night 2, set to deliver positive pressure airway ventilation. The control group will not receive CPAP on night 2. The CPAP devices to be used are the ResMed S9 and the Philips Respironics REMstar Pro, both of which are automatically setting machines that respond to the presence of snoring, partial airway obstruction and complete apneas and increase airway pressure to a therapeutic level. These systems are commercially available and in widespread everyday routine clinical use in Australia. Nasal CPAP has been used for over 30 years including in pregnant women and has been found to be very safe therapy.
DURATION Participants will be required to undertake 2 overnight sleep studies/BP monitors/CO2 monitors and complete a 10 minute questionnaire in the first 6 weeks post-partum. The study will be undertaken between 1/6/14 to 1/6/16.
INVESTIGATION PLAN Following informed consent participants will be enrolled to undergo the following investigational plan.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women 24-37 weeks pregnant
- •Singleton pregnancy
- •Primiparous and primigravid
- •Maternal age 18-45 years
- •Diagnosis of preeclampsia by their treating specialist (SBP>140/90 and proteinuria>300mg in 24 hours)
排除标准
- •A previous diagnosis of hypertension, cardiac, respiratory or renal disease.
- •Any regular cardiac or respiratory medications (PRIOR to pregnancy and diagnosis of preeclampsia)
- •Current smokers
研究组 & 干预措施
Control
The control group will not be fitted with CPAP.
CPAP group
The group will wear a CPAP device throughout the night. The mask fits comfortably over the nose and delivers a steady stream of air under slight pressure (auto-set).
干预措施: Continuous Positive Airway Pressure Ventilation (CPAP) (Device)
结局指标
主要结局
Fetal movements
时间窗: 2 days
Fetal movements will be measured throughout the night for 2 consecutive nights (night 1 and night 2-intervention). This will be used to calculate average fetal movements per hour in each of the 2 groups.
Maternal Blood Pressure
时间窗: 2 days
Maternal blood pressure will be measured hourly for 48 hours during the 2 days of the study. This will be used to compare average nocturnal and daytime blood pressures between the first and 2nd (intervention) night in the 2 groups.
次要结局
未报告次要终点
研究者
Professor David Celermajer
Professor
University of Sydney