Wireless Physiologic Monitoring in Postpartum Women

NCT04060667 | Active Not Recruiting Results DMC

• 2 other identifiers: 2019P000885K23HD097300-01
• Study Type: interventional
• Target: 3,191
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (1)

• Severe Maternal Outcome

  The primary effectiveness outcome was a composite measure of severe maternal morbidity (SMM) measured from enrollment until hospital discharge This composite measure is adapted from World Health Organization (WHO) near-miss morbidity criteria, as well as other severe maternal outcomes, including hysterectomy, cardiac arrest, prolonged unconsciousness, stroke, dialysis, intensive care admission, and death.

  From completion of the cesarean delivery until hospital discharge from the procedure, an average of 3 days

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Combination Product: Wireless physiologic monitoring

control

NO INTERVENTION

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

Interventions

Wireless physiologic monitoring COMBINATION_PRODUCT

The intervention in this study is the use of a wireless monitor to perform physiologic monitoring of women undergoing emergency cesarean delivery for the first 24 hours after completion of the cesarean and send alerts to responding clinicians should vital signs fall out of a pre-specified range.

Also known as: vital sign abnormality alerts

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Admitted to ICU directly after delivery
• Allergies or hypersensitivity to device materials

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Mbarara University of Science and Technology: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Mbarara Regional Referral Hospital

Mbarara, Uganda

Location

Related Publications (1)

• 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.

  PMID: 33579213 DERIVED

MeSH Terms

Conditions

Pregnancy Complications; Maternal Death

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Parental Death; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Adeline Boatin
• Organization: Massachusetts General Hospital

adeline_boatin@mgh.harvard.edu

617 724 61320

Study Officials

• Adeline A Boatin, MD MPH

  MGH

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of OB/GYN

Model Details: describe time blocks, include description of time allotment

Study Record Dates

• First Submitted: July 31, 2019
• First Posted: August 19, 2019
• Study Start: January 21, 2020
• Primary Completion: March 30, 2022
• Study Completion: December 31, 2025
• Last Updated: September 9, 2025
• Results First Posted: September 9, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)