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Wireless Physiologic Monitoring in Postpartum Women — WIMS  

Pregnancy Complications Clinical Trial

Official title:
Wireless Physiologic Monitoring in Postpartum Women

Clinical Trial 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

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04060667
Study type Interventional
Source Massachusetts General Hospital
Contact Adeline A Boatin, MD MPH
Phone 6176434928
Email adeline_boatin@mgh.harvard.edu
Status Recruiting
Phase N/A
Start date January 21, 2020
Completion date September 30, 2021
View Details
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