Wireless Physiologic Monitoring in Postpartum Women

Study Overview
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Brief Summary
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To estimate the clinical effectiveness of wireless physiologic monitoring of women in the first 24 hours after cesarean delivery at Mbarara Regional Referral Hospital

Detailed Description
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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.

Official Title
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Wireless Physiologic Monitoring in Postpartum Women

Conditions
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Maternal Death During Childbirth, Pregnancy Complications

Intervention / Treatment
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* Combination Product: Wireless physiologic monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Admitted to ICU directly after delivery Allergies or hypersensitivity to device materials

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: describe time blocks, include description of time allotment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br> | Combination Product: Wireless physiologic monitoring<br>* The intervention in this study is the use of a wireless monitor to perform physiologic monitoring of women undergoing emergency cesarean delivery for the first 24 hours after completion of the cesarean and send alerts to responding clinicians should vital signs fall out of a pre-specified range.<br>* Other names: vital sign abnormality alerts;|
| No Intervention: control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severe maternal Outcome | This is a composite measure drawn from WHO near miss morbidity criteria | From completion of the cesarean delivery until hospital discharge, an average of 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal Mortality Rate | Number of maternal deaths per total number of deliveries | From completion of the cesarean delivery until hospital discharge, an average of 3 days | 
| Maternal near miss rate | Number of maternal near misses (per WHO criteria) per total number of deliveries | From completion of the cesarean delivery until hospital discharge, an average of 3 days | 
| Disease Specific Case fatality rate | case fatality rate for specific pregnancy complications (postpartum hemorrhage, hypertensive disease, sepsis) | From completion of the cesarean delivery until hospital discharge, an average of 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vital sign monitoring, maternal near miss, maternal mortality, maternal morbidity, physiologic monitoring, quality of care, inpatient monitoring