Wireless Physiologic Monitoring in Postpartum Women (WIMS)

Mass General Brigham

Status: Active, not recruiting

Conditions: Pregnancy Complications; Maternal Death During Childbirth

Treatments: Combination Product: Wireless physiologic monitoring

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04060667

K23HD097300-01 (U.S. NIH Grant/Contract)

2019P000885

Details and patient eligibility

About

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

Full 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.

Enrollment: 3,191 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,191 participants in 2 patient groups

Intervention

Experimental group

Description:

Participants in the intervention arm were monitored for up to 24 hours after an emergency cesarean section using the Current Health wireless physiologic monitoring system, which includes a wearable biosensor that records heart rate, temperature, respiratory rate, oxygen saturation, and movement continuously and transmits data in real-time via a wireless network to the cloud.

Treatment:

Combination Product: Wireless physiologic monitoring

control

No Intervention group

Description:

Participants in the control arm had standard of care monitoring, using available tools on the wards (manual heart rate, temperature, and respiratory rate calculations).