Clinical trial NCT04060667: Wireless Physiologic Monitoring in Postpartum Women
Official title: Wireless Physiologic Monitoring in Postpartum Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Maternal Death During Childbirth
Pregnancy Complications
Keywords: vital sign monitoring
maternal near miss
maternal mortality
maternal morbidity
physiologic monitoring
quality of care
inpatient monitoring
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Mbarara University of Science and Technology
First posted: 2019-08-19
Enrollment: 2462
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: describe time blocks, include description of time allotment
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Severe maternal Outcome
timeFrame: From completion of the cesarean delivery until hospital discharge, an average of 3 days
Secondary outcomes:
measure: Maternal Mortality Rate
timeFrame: From completion of the cesarean delivery until hospital discharge, an average of 3 days
measure: Maternal near miss rate
timeFrame: From completion of the cesarean delivery until hospital discharge, an average of 3 days
measure: Disease Specific Case fatality rate
timeFrame: From completion of the cesarean delivery until hospital discharge, an average of 3 days
Other outcomes:
Locations:
city: Mbarara
country: Uganda
facility: Mbarara Regional Referral Hospital
Study officials:
affiliation: MGH
name: Adeline A Boatin, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boatin AA, Ngonzi J, Wylie BJ, Lugobe HM, Bebell LM, Mugyenyi G, Mohamed S, Martinez K, Musinguzi N, Psaros C, Metlay JP, Haberer JE. Wireless versus routine physiologic monitoring after cesarean delivery to reduce maternal morbidity and mortality in a resource-limited setting: protocol of type 2 hybrid effectiveness-implementation study. BMC Pregnancy Childbirth. 2021 Feb 12;21(1):124. doi: 10.1186/s12884-021-03550-w.