Wireless Physiologic Monitoring in Postpartum Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,191
- 试验地点
- 1
- 主要终点
- Severe Maternal Outcome
研究概览
简要总结
To estimate the clinical effectiveness of wireless physiologic monitoring of women in the first 24 hours after cesarean delivery at Mbarara Regional Referral Hospital
详细描述
Women in sub-Saharan Africa have the highest rates of morbidity and mortality during childbirth. Despite significant increases in facility-based childbirth, quality gaps at the facility have limited reductions in maternal deaths. Infrequent monitoring of women around childbirth is a major gap in care that leads to delays in life-saving interventions. Simple increases in staffing will not overcome this gap, thus necessitating new strategies.
This project aims to use a simple wireless monitor to improve the detection of complications immediately after childbirth and allow clinicians to provide life-saving interventions when needed. Using a hybrid clinical effectiveness-implementation approach women delivered by cesarean in Mbarara, Uganda will be recruited to wear a wireless physiologic monitor for 24 hours after delivery and their delivering obstetricians recruited to use the monitoring system, including the receipt of text message alerts should women develop abnormalities in physiologic signs. Rates of morbidity and mortality will be compared with a control group of women delivered by the same obstetricians. Clinical adoption and implementation will be assessed with the RE-AIM implementation framework and semi-structured interviews.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Emergency cesarean delivery at MRRH
- •Able to provide consent or have a guardian/attendant present who can consent
- •Willing to wear the biosensor for 24 hours
- •Willing remain in the postpartum unit for 24 hours
排除标准
- •Admitted to ICU directly after delivery
- •Allergies or hypersensitivity to device materials
研究组 & 干预措施
Intervention
Participants in the intervention arm were monitored for up to 24 hours after an emergency cesarean section using the Current Health wireless physiologic monitoring system, which includes a wearable biosensor that records heart rate, temperature, respiratory rate, oxygen saturation, and movement continuously and transmits data in real-time via a wireless network to the cloud.
干预措施: Wireless physiologic monitoring (Combination Product)
control
Participants in the control arm had standard of care monitoring, using available tools on the wards (manual heart rate, temperature, and respiratory rate calculations).
结局指标
主要结局
Severe Maternal Outcome
时间窗: From completion of the cesarean delivery until hospital discharge from the procedure, an average of 3 days
The primary effectiveness outcome was a composite measure of severe maternal morbidity (SMM) measured from enrollment until hospital discharge This composite measure is adapted from World Health Organization (WHO) near-miss morbidity criteria, as well as other severe maternal outcomes, including hysterectomy, cardiac arrest, prolonged unconsciousness, stroke, dialysis, intensive care admission, and death.
Severe Maternal Outcome
时间窗: From completion of the cesarean delivery until hospital discharge from the procedure, an average of 3 days
The primary effectiveness outcome was a composite measure of severe maternal morbidity (SMM) measured from enrollment until hospital discharge This composite measure is adapted from World Health Organization (WHO) near-miss morbidity criteria, as well as other severe maternal outcomes, including hysterectomy, cardiac arrest, prolonged unconsciousness, stroke, dialysis, intensive care admission, and death.
次要结局
未报告次要终点
研究者
Adeline A Boatin
Assistant Professor of OB/GYN
Massachusetts General Hospital
