Wireless Physiologic Monitoring in Postpartum Women (WIMS)

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

Study Overview

• Status: Unknown
• Conditions: Pregnancy Complications; Maternal Death During Childbirth
• Intervention / Treatment: Combination product: Wireless physiologic monitoring

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.

• Study Type: Interventional
• Enrollment (Anticipated): 2462
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adeline A Boatin, MD MPH; Phone Number: 6176434928; Email: adeline_boatin@mgh.harvard.edu
• Study Contact Backup: Name: Joseph Ngonzi, MBCHB, MMED; Email: jngonzi@yahoo.com

Study Locations

• Uganda
  • Mbarara, Uganda
    • Recruiting
    • Mbarara Regional Referral Hospital
    • Contact: Joseph Ngonzi; Phone Number: +256 70381833; Email: jngonzi@must.ac.ug
    • Contact: Henry Lugobe; Phone Number: +256 774 030 593

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention	Combination product: Wireless physiologic monitoring; 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.; Other Names: vital sign abnormality alerts
No Intervention: control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severe maternal Outcome	This is a composite measure drawn from WHO near miss morbidity criteria	From completion of the cesarean delivery until hospital discharge, an average of 3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal Mortality Rate	Number of maternal deaths per total number of deliveries	From completion of the cesarean delivery until hospital discharge, an average of 3 days
Maternal near miss rate	Number of maternal near misses (per WHO criteria) per total number of deliveries	From completion of the cesarean delivery until hospital discharge, an average of 3 days
Disease Specific Case fatality rate	case fatality rate for specific pregnancy complications (postpartum hemorrhage, hypertensive disease, sepsis)	From completion of the cesarean delivery until hospital discharge, an average of 3 days

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Mbarara University of Science and Technology
• Investigators: Principal Investigator: Adeline A Boatin, MD MPH, MGH

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2020
• Primary Completion (Anticipated): July 15, 2021
• Study Completion (Anticipated): September 30, 2021

Study Registration Dates

• First Submitted: July 31, 2019
• First Submitted That Met QC Criteria: August 16, 2019
• First Posted (Actual): August 19, 2019

Study Record Updates

• Last Update Posted (Actual): September 10, 2020
• Last Update Submitted That Met QC Criteria: September 8, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: quality of care; maternal morbidity; maternal mortality; vital sign monitoring; maternal near miss; physiologic monitoring; inpatient monitoring
• Additional Relevant MeSH Terms: Pathologic Processes; Death; Parental Death; Pregnancy Complications; Maternal Death
• Other Study ID Numbers: 2019P000885; K23HD097300-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No