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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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12 December 2020 |
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Main ID: |
NCT02416089 |
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Date of registration:
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16/03/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Tampostat for Management of Postpartum Hemorrhage
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Scientific title:
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Tampostat: A Low-cost, Self-regulating Tamponade for Management of Postpartum Hemorrhage in Bangladesh |
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Date of first enrolment:
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April 2015 |
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Target sample size:
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344 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02416089 |
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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: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Bangladesh
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Contacts
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Name:
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Aminur Rahman, MBBS,MSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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International Centre for Diarrhoeal Disease Research, Bangladesh |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Women who delivered their baby at the site hospital, or attended the site hospital
with PPH that started within the last 24 hours.
2. Women with primary PPH have received AMTSL.
3. PPH is due to atonic uterus.
4. Provides written informed consent for enrolment in the study.
Exclusion Criteria:
1. Primary PPH caused by retained placenta or ruptured uterus.
2. Women who delivered before 28 weeks of gestation.
3. Women not willing to participate in the study.
Age minimum:
N/A
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Postpartum Hemorrhage
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Intervention(s)
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Device: Tampostat
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Device: Condom catheter tamponade
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Primary Outcome(s)
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Comparison of the efficacy of Tampostat as measured by number of successful cases in arresting primary PPH and the time takes to arrest the bleeding with that of the condom catheter tamponade
[Time Frame: 12 months]
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Efficacy of Tampostat as measured by number of successful cases in arresting bleeding in Primary PPH
[Time Frame: 12 months]
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Safety of Tampostat as measured by number of serious adverse events in primary PPH management
[Time Frame: 2 months]
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Secondary Outcome(s)
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Feasibility as measured by number of physicians consider Tampostat as a feasible device in arresting primary PPH
[Time Frame: 2 months]
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Applicability of Tampostat as measured by rating by service providers using pre established scoring system in the management of primary PPH
[Time Frame: 2 months]
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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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