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Wireless Physiologic Monitoring in Postpartum Women (WIMS)

Primary Purpose

Maternal Death During Childbirth, Pregnancy Complications

Status
Unknown status
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
Wireless physiologic monitoring
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Maternal Death During Childbirth focused on measuring vital sign monitoring, maternal near miss, maternal mortality, maternal morbidity, physiologic monitoring, quality of care, inpatient monitoring

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Mbarara Regional Referral HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

control

Arm Description

Outcomes

Primary Outcome Measures

Severe maternal Outcome
This is a composite measure drawn from WHO near miss morbidity criteria

Secondary Outcome Measures

Maternal Mortality Rate
Number of maternal deaths per total number of deliveries
Maternal near miss rate
Number of maternal near misses (per WHO criteria) per total number of deliveries
Disease Specific Case fatality rate
case fatality rate for specific pregnancy complications (postpartum hemorrhage, hypertensive disease, sepsis)

Full Information

First Posted
July 31, 2019
Last Updated
September 8, 2020
Sponsor
Massachusetts General Hospital
Collaborators
Mbarara University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT04060667
Brief Title
Wireless Physiologic Monitoring in Postpartum Women
Acronym
WIMS
Official Title
Wireless Physiologic Monitoring in Postpartum Women
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 21, 2020 (Actual)
Primary Completion Date
July 15, 2021 (Anticipated)
Study Completion Date
September 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Mbarara University of Science and Technology

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maternal Death During Childbirth, Pregnancy Complications
Keywords
vital sign monitoring, maternal near miss, maternal mortality, maternal morbidity, physiologic monitoring, quality of care, inpatient monitoring

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
describe time blocks, include description of time allotment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2462 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Title
control
Arm Type
No Intervention
Intervention Type
Combination Product
Intervention Name(s)
Wireless physiologic monitoring
Other Intervention Name(s)
vital sign abnormality alerts
Intervention Description
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.
Primary Outcome Measure Information:
Title
Severe maternal Outcome
Description
This is a composite measure drawn from WHO near miss morbidity criteria
Time Frame
From completion of the cesarean delivery until hospital discharge, an average of 3 days
Secondary Outcome Measure Information:
Title
Maternal Mortality Rate
Description
Number of maternal deaths per total number of deliveries
Time Frame
From completion of the cesarean delivery until hospital discharge, an average of 3 days
Title
Maternal near miss rate
Description
Number of maternal near misses (per WHO criteria) per total number of deliveries
Time Frame
From completion of the cesarean delivery until hospital discharge, an average of 3 days
Title
Disease Specific Case fatality rate
Description
case fatality rate for specific pregnancy complications (postpartum hemorrhage, hypertensive disease, sepsis)
Time Frame
From completion of the cesarean delivery until hospital discharge, an average of 3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adeline A Boatin, MD MPH
Phone
6176434928
Email
adeline_boatin@mgh.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Joseph Ngonzi, MBCHB, MMED
Email
jngonzi@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adeline A Boatin, MD MPH
Organizational Affiliation
MGH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mbarara Regional Referral Hospital
City
Mbarara
Country
Uganda
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Ngonzi
Phone
+256 70381833
Email
jngonzi@must.ac.ug
First Name & Middle Initial & Last Name & Degree
Henry Lugobe
Phone
+256 774 030 593

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33579213
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.
Results Reference
derived

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Wireless Physiologic Monitoring in Postpartum Women

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