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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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16 December 2017 |
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Main ID: |
NCT02790814 |
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Date of registration:
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01/06/2016 |
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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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Moyo; strap-on Fetal Heart Rate Monitoring in a Rural Setting
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Scientific title:
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Evaluation of an Innovative Fetal Heart Rate Monitoring Device (Named Moyo) to Improve Perinatal Outcome at Haydom Hospital, Tanzania |
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Date of first enrolment:
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February 2016 |
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Target sample size:
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2652 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02790814 |
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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: Crossover Assignment. Primary purpose: Diagnostic. 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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Tanzania
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Contacts
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Name:
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Hege L. Ersdal, Md PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Stavanger University Hospital, Norway |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Women admitted in labor
Exclusion Criteria:
- Women scheduled for elective cesarean section, women with abnormal fetal heart rate on
admission, multiples, and critically ill patients with no measurements of fetal heart
rate on admission
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Fetal Monitoring
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Intervention(s)
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Device: Hand-held fetoscope
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Device: Moyo strap-on
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Primary Outcome(s)
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Frequency of abnormal fetal heart rate detection
[Time Frame: Up to delivery]
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Secondary Outcome(s)
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Time from abnormal fetal heart rate detection to delivery in minutes
[Time Frame: Up to delivery]
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Neonatal outcome: dead versus alive
[Time Frame: Up to 24 hours]
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Mode of delivery: vaginal versus operative
[Time Frame: Up to delivery]
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Secondary ID(s)
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Moyo Rural
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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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