Pregnancy Complications Clinical Trial
Official title:
Wireless Physiologic Monitoring in Postpartum Women
To estimate the clinical effectiveness of wireless physiologic monitoring of women in the first 24 hours after cesarean delivery at Mbarara Regional Referral Hospital
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.
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