Maternal Death During ChildbirthWIMSNCT04060667
Wireless Physiologic Monitoring in Postpartum Women
A study testing Wireless physiologic monitoring in people with Maternal Death During Childbirth and Pregnancy Complications, run by Massachusetts General Hospital at 1 site in Uganda.
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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Maternal Death During Childbirth, Pregnancy Complications
- What is being tested?
- Wireless physiologic monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,191 participants
- Where
- 1 siteUganda
- Study dates
- 21 Jan 2020to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Admitted to ICU directly after delivery
- Allergies or hypersensitivity to device materials
Trial locations and contacts
1 site in 1 country.
About this study
To estimate the clinical effectiveness of wireless physiologic monitoring of women in the first 24 hours after cesarean delivery at Mbarara Regional Referral Hospital
Read the 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.
- Being tested
- Wireless physiologic monitoring
- Keywords
- vital sign monitoring, maternal near miss, maternal mortality, maternal morbidity, physiologic monitoring, quality of care, inpatient monitoring
- Medical subject headings
- Pregnancy Complications, Maternal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wireless physiologic monitoringCombination product
Also called vital sign abnormality alerts
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Combination Product: Wireless physiologic monitoring |
| control | No intervention | Participants in the control arm had standard of care monitoring, using available tools on the wards (manual heart rate, temperature, and respiratory rate calculations). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From completion of the cesarean delivery until hospital discharge from the procedure, an average of 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2019
- Study start21 Jan 2020
- Primary completion30 Mar 2022
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Maternal Death During ChildbirthStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- describe time blocks, include description of time allotment
- Masking
- None (open label)
- Enrolment
- 3,191 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Mbarara University of Science and Technology, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Adeline A Boatin, Massachusetts General Hospital
- Investigators
- Adeline A Boatin, MD MPH, Principal investigator, MGH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04060667
- Sponsor's protocol ID
- 2019P000885
- Other IDs
- K23HD097300-01
- Acronym
- WIMS
- Status last verified
- Jul 2026
- First submitted
- 31 Jul 2019
- Last updated
- 23 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33579213
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wireless Physiologic Monitoring in Postpartum Women
- ClinicalTrials.gov ID
- NCT04060667
- Acronym / sponsor ID
- WIMS / 2019P000885
- Keywords
- vital sign monitoring, maternal near miss, maternal mortality, maternal morbidity, physiologic monitoring, quality of care, inpatient monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,191 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Mbarara University of Science and Technology, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 21 Jan 2020 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 19 Aug 2019 (actual)
- Results
- Posted 9 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- describe time blocks, include description of time allotment
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Combination Product: Wireless physiologic monitoringParticipants 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. |
| control | No intervention | –Participants in the control arm had standard of care monitoring, using available tools on the wards (manual heart rate, temperature, and respiratory rate calculations). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Admitted to ICU directly after delivery
- Allergies or hypersensitivity to device materials
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wireless physiologic monitoringAlso: vital sign abnormality alertsThe 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. | Combination product | Intervention |
Primary outcome
Severe Maternal Outcome
Time frame: From completion of the cesarean delivery until hospital discharge from the procedure, an average of 3 days
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33579213Boatin 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adeline A Boatin, MD MPH principal investigator
MGH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wireless physiologic monitoring in people with Maternal Death During Childbirth and Pregnancy Complications, run by Massachusetts General Hospital at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe Maternal Outcome (time frame: From completion of the cesarean delivery until hospital discharge from the procedure, an average of 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04060667, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.