Wireless Physiologic Monitoring in Postpartum Women

Pregnancy Complications Clinical Trial

— WIMS  

Official title:

Wireless Physiologic Monitoring in Postpartum Women

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04060667
• Other study ID #: 2019P000885
• Secondary ID: K23HD097300-01
• Status: Recruiting
• Phase: N/A
• Start date: January 21, 2020
• Est. completion date: September 30, 2021

Study information

• Verified date: September 2020
• Source: Massachusetts General Hospital
• Contact: Adeline A Boatin, MD MPH
• Phone: 6176434928
• Email: adeline_boatin[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2462
• Est. completion date: September 30, 2021
• Est. primary completion date: July 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Maternal Death
• Maternal Death During Childbirth
• Pregnancy Complications

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.

Locations

Country	Name	City	State
Uganda	Mbarara Regional Referral Hospital	Mbarara

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Mbarara University of Science and Technology

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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