Trial Outcomes & Findings for Wireless Physiologic Monitoring in Postpartum Women (NCT NCT04060667)

Last Updated: 2025-09-09

Results Overview

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.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

Target enrollment

3191 participants

Primary outcome timeframe

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

Results posted on

2025-09-09

Participant Flow

This is a study in which a single health facility was assigned to alternating two-week "intervention" and "control" periods. During the intervention periods, participants were consented, and received the study intervention. During the control periods, participants received standard of care and medical record review only was performed. Consent was waived for participants in the control periods.

Participant milestones

Participant milestones
Measure	Intervention Wireless Physiologic Monitoring	Control Standard of Care
Overall Study STARTED	1552	1639
Overall Study COMPLETED	1477	1629
Overall Study NOT COMPLETED	75	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Intervention Wireless Physiologic Monitoring	Control Standard of Care
Overall Study Lost to Follow-up	75	10

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=1552 Participants 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.	Control n=1629 Participants Standard of Care monitoring	Total n=3181 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=1552 Participants	0 Participants n=1629 Participants	0 Participants n=3181 Participants
Age, Categorical Between 18 and 65 years	1552 Participants n=1552 Participants	1629 Participants n=1629 Participants	3181 Participants n=3181 Participants
Age, Categorical >=65 years	0 Participants n=1552 Participants	0 Participants n=1629 Participants	0 Participants n=3181 Participants
Age, Continuous	26.0 years STANDARD_DEVIATION 5.4 • n=1552 Participants	26.6 years STANDARD_DEVIATION 5.8 • n=1629 Participants	26.3 years STANDARD_DEVIATION 5.6 • n=3181 Participants
Sex: Female, Male Female	1552 Participants n=1552 Participants	1629 Participants n=1629 Participants	3181 Participants n=3181 Participants
Sex: Female, Male Male	0 Participants n=1552 Participants	0 Participants n=1629 Participants	0 Participants n=3181 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Parity	2.2 number of pregnancies STANDARD_DEVIATION 1.6 • n=1552 Participants	2.2 number of pregnancies STANDARD_DEVIATION 1.5 • n=1629 Participants	2.2 number of pregnancies STANDARD_DEVIATION 1.5 • n=3181 Participants
Gestational Age	39.1 completed weeks of gestation STANDARD_DEVIATION 2.5 • n=1546 Participants • Missing data	39.2 completed weeks of gestation STANDARD_DEVIATION 2.5 • n=1629 Participants • Missing data	39.1 completed weeks of gestation STANDARD_DEVIATION 2.5 • n=3175 Participants • Missing data

PRIMARY outcome

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

Population: Analysis was restricted to participants consenting for participation (intervention group) or with completed medical record review (control group)

Outcome measures

Outcome measures
Measure	Intervention n=1552 Participants 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.	Control n=1639 Participants Standard of Care
Severe Maternal Outcome	25 participants	25 participants

Adverse Events

Intervention

Serious events: 6 serious events

Other events: 0 other events

Deaths: 3 deaths

Control

Serious events: 12 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Intervention n=1552 participants at risk 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.	Control n=1629 participants at risk Standard of Care monitoring
Reproductive system and breast disorders Hysterectomy	0.19% 3/1552 • Number of events 3 • Until hospital discharge, an average of 3 days Our primary outcome measure was severe maternal outcome; the outcomes collected as part of this composite outcome include: blood transfusion, hysterectomy, cardiac arrest, prolonged unconsciousness, stroke, dialysis, intensive care admission, and death	0.37% 6/1629 • Number of events 6 • Until hospital discharge, an average of 3 days Our primary outcome measure was severe maternal outcome; the outcomes collected as part of this composite outcome include: blood transfusion, hysterectomy, cardiac arrest, prolonged unconsciousness, stroke, dialysis, intensive care admission, and death
Surgical and medical procedures Re-operation	0.06% 1/1552 • Number of events 1 • Until hospital discharge, an average of 3 days Our primary outcome measure was severe maternal outcome; the outcomes collected as part of this composite outcome include: blood transfusion, hysterectomy, cardiac arrest, prolonged unconsciousness, stroke, dialysis, intensive care admission, and death	0.12% 2/1629 • Number of events 2 • Until hospital discharge, an average of 3 days Our primary outcome measure was severe maternal outcome; the outcomes collected as part of this composite outcome include: blood transfusion, hysterectomy, cardiac arrest, prolonged unconsciousness, stroke, dialysis, intensive care admission, and death
Surgical and medical procedures ICU admission	0.13% 2/1552 • Number of events 2 • Until hospital discharge, an average of 3 days Our primary outcome measure was severe maternal outcome; the outcomes collected as part of this composite outcome include: blood transfusion, hysterectomy, cardiac arrest, prolonged unconsciousness, stroke, dialysis, intensive care admission, and death	0.18% 3/1629 • Number of events 3 • Until hospital discharge, an average of 3 days Our primary outcome measure was severe maternal outcome; the outcomes collected as part of this composite outcome include: blood transfusion, hysterectomy, cardiac arrest, prolonged unconsciousness, stroke, dialysis, intensive care admission, and death
Cardiac disorders cardiac arrest	0.00% 0/1552 • Until hospital discharge, an average of 3 days Our primary outcome measure was severe maternal outcome; the outcomes collected as part of this composite outcome include: blood transfusion, hysterectomy, cardiac arrest, prolonged unconsciousness, stroke, dialysis, intensive care admission, and death	0.06% 1/1629 • Number of events 1 • Until hospital discharge, an average of 3 days Our primary outcome measure was severe maternal outcome; the outcomes collected as part of this composite outcome include: blood transfusion, hysterectomy, cardiac arrest, prolonged unconsciousness, stroke, dialysis, intensive care admission, and death

Other adverse events

Adverse event data not reported

Additional Information

Adeline Boatin

Massachusetts General Hospital

Phone: 617 724 61320

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place