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临床试验/NCT04060667
NCT04060667已完成不适用

Wireless Physiologic Monitoring in Postpartum Women

Massachusetts General Hospital1 个研究点 分布在 1 个国家目标入组 3,191 人开始时间: 2020年1月21日最近更新:
适应症
干预措施

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

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

Experimental

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

No Intervention

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Adeline A Boatin

Assistant Professor of OB/GYN

Massachusetts General Hospital

研究点 (1)

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