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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: |
NCT02805426 |
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Date of registration:
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09/03/2016 |
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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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Effectiveness of Tranexamic Acid When Used as an Adjunct to Misoprostol for the Treatment of Postpartum Hemorrhage
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Scientific title:
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Double-blind, Randomized Controlled Trial to Assess the Effectiveness of Tranexamic Acid When Used as an Adjunct to Misoprostol for the Treatment of Postpartum Hemorrhage |
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Date of first enrolment:
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October 2016 |
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Target sample size:
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260 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02805426 |
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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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 4
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Countries of recruitment
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Senegal
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Vietnam
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Contacts
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Name:
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Dina Abbas, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Gynuity Health Projects |
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Name:
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Jill Durocher |
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Address:
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Telephone:
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Email:
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Affiliation:
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Gynuity Health Projects |
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Name:
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Ayisha Diop, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Gynuity Health Projects |
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Name:
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Nguyen thi Nhu Ngoc, MD, 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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CRCRH |
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Name:
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Beverly Winikoff, MD, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Gynuity Health Projects |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Women who delivery vaginally
- Women who experience PPH defined as blood loss =700ml
- Women capable of giving consent
Exclusion Criteria:
- Clear contraindication for tranexamic acid such as known allergy or thromboembolic
event during pregnancy
- Women delivering via cesarean section
- Provider feels that the woman, at presentation for delivery, is not in a position to
give appropriate informed consent
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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Drug: Misoprostol
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Drug: Placebo
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Drug: Tranexamic Acid
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Primary Outcome(s)
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Proportion of women with bleeding controlled with the study regimens alone, without recourse to further treatment in each study arm
[Time Frame: 20 minutes after initial study treatment]
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Secondary Outcome(s)
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Mean/median blood loss
[Time Frame: at two hours after treatment]
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Proportion of women who experience side effects
[Time Frame: 2 hours after delivery]
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Proportion of women who received additional drugs
[Time Frame: 2 hours after delivery]
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Use of uterotonic agents after initial treatment
[Time Frame: 2 hours after delivery]
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Rate of severe PPH
[Time Frame: 2 hours after delivery]
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Adverse events
[Time Frame: 48 hours after delivery]
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Proportion of women with controlled bleeding
[Time Frame: At various time intervals after study treatment (20, 40, 60, 120 mins)]
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Proportion of women who receive additional intervention
[Time Frame: 2 hours after delivery]
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Proportion of women who received a serious interventions
[Time Frame: 2 hours after delivery]
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Proportion of women who find the treatment tolerable
[Time Frame: 48 hours after delivery]
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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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