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| ID | Type | Description | Link |
|---|---|---|---|
| K23HD097300-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Mbarara University of Science and Technology | OTHER |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wireless physiologic monitoring | Combination Product | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From completion of the cesarean delivery until hospital discharge from the procedure, an average of 3 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adeline A Boatin, MD MPH | MGH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mbarara Regional Referral Hospital | Mbarara | Uganda |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33579213 | Derived | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Wireless Physiologic Monitoring |
| FG001 | Control | Standard of Care |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Analysis was restricted to participants consenting for participation (intervention group) or with completed medical record review (control group) | Posted | Number | participants | From completion of the cesarean delivery until hospital discharge from the procedure, an average of 3 days |
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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
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hysterectomy | Reproductive system and breast disorders | Systematic Assessment | Removal of the uterus |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Adeline Boatin | Massachusetts General Hospital | 617 724 61320 | adeline_boatin@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 20, 2021 | Aug 19, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 26, 2021 | Aug 19, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D063130 | Maternal Death |
| ID | Term |
|---|---|
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D063129 | Parental Death |
| D003643 | Death |
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describe time blocks, include description of time allotment
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| BG001 |
| Control |
Standard of Care monitoring |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Parity | Mean | Standard Deviation | number of pregnancies |
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| Gestational Age | Missing data | Mean | Standard Deviation | completed weeks of gestation |
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| OG001 | Control | Standard of Care |
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| 3 |
| 1,552 |
| 6 |
| 1,552 |
| 0 |
| 1,552 |
| EG001 | Control | Standard of Care monitoring | 1 | 1,629 | 12 | 1,629 | 0 | 1,629 |
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| Re-operation | Surgical and medical procedures | Systematic Assessment | Need for re-operation after the initial surgery (cesarean delivery) |
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| ICU admission | Surgical and medical procedures | Systematic Assessment | admission to the intensive care unit |
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| cardiac arrest | Cardiac disorders | Systematic Assessment | need for cardiopulmonary resuscitation |
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| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |