An interventional study of Wireless physiologic monitoring in Maternal Death During Childbirth and Pregnancy Complications, sponsored by Massachusetts General Hospital. Completed at 1 site in Uganda. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-23.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Health services research
To estimate the clinical effectiveness of wireless physiologic monitoring of women in the first 24 hours after cesarean delivery at Mbarara Regional Referral Hospital
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.
Exclusion Criteria:
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
Participants in the control arm had standard of care monitoring, using available tools on the wards (manual heart rate, temperature, and respiratory rate calculations).
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
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.
Time frame: From completion of the cesarean delivery until hospital discharge from the procedure, an average of 3 days
| Milestone | Intervention | Control |
|---|---|---|
| Started | 1552 | 1639 |
| Completed | 1477 | 1629 |
| Not completed | 75 | 10 |
| Withdrew: Lost to follow-up | 75 | 10 |
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.
| participants | Intervention | Control |
|---|---|---|
| Severe Maternal Outcome | 25 | 25 |
Collected over Until hospital discharge, an average of 3 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention | 3/1,552 (0.2%) | 6/1,552 (0.4%) | 0/1,552 (0%) |
| Control | 1/1,629 (0.1%) | 12/1,629 (0.7%) | 0/1,629 (0%) |
| Event | Intervention | Control |
|---|---|---|
| HysterectomyReproductive system and breast disorders | 3/1552 | 6/1629 |
| ICU admissionSurgical and medical procedures | 2/1552 | 3/1629 |
| Re-operationSurgical and medical procedures | 1/1552 | 2/1629 |
| cardiac arrestCardiac disorders | 0/1552 | 1/1629 |
| Age, Categorical(Participants) | Intervention | Control | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 1552 | 1629 | 3181 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Intervention | Control | Total |
|---|---|---|---|
| Mean | 26.0 ± 5.4 | 26.6 ± 5.8 | 26.3 ± 5.6 |
| Sex: Female, Male(Participants) | Intervention | Control | Total |
|---|---|---|---|
| Female | 1552 | 1629 | 3181 |
| Male | 0 | 0 | 0 |
| Race and Ethnicity Not Collected(Participants) | Intervention | Control | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Parity(number of pregnancies) | Intervention | Control | Total |
|---|---|---|---|
| Mean | 2.2 ± 1.6 | 2.2 ± 1.5 | 2.2 ± 1.5 |
| Gestational Age(completed weeks of gestation) | Intervention | Control | Total |
|---|---|---|---|
| Mean | 39.1 ± 2.5 | 39.2 ± 2.5 | 39.1 ± 2.5 |
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Massachusetts General Hospital