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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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25 July 2023 |
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Main ID: |
NCT02909179 |
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Date of registration:
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19/09/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Measuring the Impact of a Mobile Health System to Support Healthy Pregnancies and Improve Newborn Survival
mCARE-II |
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Scientific title:
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mCARE II: Enhancing, Integrating and Scaling mCARE and Measuring the Impact of a Mobile Health System to Support Healthy Pregnancies and Improve Newborn Survival |
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Date of first enrolment:
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June 2016 |
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Target sample size:
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113539 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT02909179 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Health Services Research. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Bangladesh
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Married women of reproductive age living with their husbands in the JiVitA study area
in Gaibandha, Bangladesh
- Consented for participation in 8 weekly pregnancy surveillance
- Self reported as being pregnant
- Infants born to eligible, enrolled women
Exclusion Criteria:
- Women who are menopausal or sterilized
- Refused to participate in 8 weekly pregnancy surveillance
Age minimum:
N/A
Age maximum:
45 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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High Neonatal Mortality
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Low Antenatal Care Service Utilization
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High Perinatal Mortality
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Low Postnatal Care Service Utilization
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Intervention(s)
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Other: mCARE-II
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Primary Outcome(s)
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Decrease in perinatal mortality
[Time Frame: 22 Weeks Gestation through the first 7 days after birth]
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Decrease in Neonatal Mortality
[Time Frame: Within 43 days after birth]
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Secondary Outcome(s)
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Increase in essential newborn care utilization
[Time Frame: Within 7 days of delivery/child birth]
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Increase in antenatal care utilization
[Time Frame: up to 34 weeks of pregnancy]
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Increase in facility-based delivery
[Time Frame: At time of delivery]
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Increase in immediate breastfeeding
[Time Frame: Within first hour of life]
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Increase in skilled birth attendance
[Time Frame: During child birth]
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Increase in postnatal care utilization
[Time Frame: Within 7 days of delivery/child birth]
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Increase in skilled birth attendance
[Time Frame: At time of delivery]
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Secondary ID(s)
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IRB00006469
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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