Wireless Physiologic Monitoring in Postpartum Women

Not Applicable

• Conditions: Maternal Death During Childbirth; Pregnancy Complications
• Interventions: Combination Product: Wireless physiologic monitoring

• Registration Number: NCT04060667
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-07-31
• Study First Submitted QC: 2019-08-16
• Study First Posted: 2019-08-19
• Study Start: 2020-01-21
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-08
• Last Update Posted: 2020-09-10
• Primary Completion: 2021-07-15
• Study Completion: 2021-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2462

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Wireless physiologic monitoring	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Mbarara Regional Referral Hospital; 🇺🇬 Mbarara, Uganda