Maternal Death During Childbirth, Pregnancy Complications
Conditions
Keywords
vital sign monitoring, maternal near miss, maternal mortality, maternal morbidity, physiologic monitoring, quality of care, inpatient monitoring
Brief 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
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.
Interventions
COMBINATION_PRODUCTWireless 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.
Sponsors
Massachusetts General Hospital
Mbarara University of Science and Technology
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
describe time blocks, include description of time allotment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severe Maternal Outcome | 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. |
Countries
Uganda
Contacts
PRINCIPAL_INVESTIGATORAdeline A Boatin, MD MPH
MGH
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 1,552 |
| Control Standard of Care monitoring | 1,629 |
| Total | 3,181 |
Baseline characteristics
| Characteristic | Intervention | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1552 Participants | 1629 Participants | 3181 Participants |
| Age, Continuous | 26.0 years STANDARD_DEVIATION 5.4 | 26.6 years STANDARD_DEVIATION 5.8 | 26.3 years STANDARD_DEVIATION 5.6 |
| Gestational Age | 39.1 completed weeks of gestation STANDARD_DEVIATION 2.5 | 39.2 completed weeks of gestation STANDARD_DEVIATION 2.5 | 39.1 completed weeks of gestation STANDARD_DEVIATION 2.5 |
| Parity | 2.2 number of pregnancies STANDARD_DEVIATION 1.6 | 2.2 number of pregnancies STANDARD_DEVIATION 1.5 | 2.2 number of pregnancies STANDARD_DEVIATION 1.5 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 1552 Participants | 1629 Participants | 3181 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 1,552 | 1 / 1,629 |
| other Total, other adverse events | 0 / 1,552 | 0 / 1,629 |
| serious Total, serious adverse events | 6 / 1,552 | 12 / 1,629 |
Outcome results
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.
Time frame: 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)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention | Severe Maternal Outcome | 25 participants |
| Control | Severe Maternal Outcome | 25 participants |