Effectiveness of Tranexamic Acid When Used as an Adjunct to Misoprostol for the Treatment of Postpartum Hemorrhage

Study Overview
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Brief Summary
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This study is a randomized, double-blind, placebo controlled trial that will enroll 250 women (125 per study arm). The objective of the study is to determine the efficacy and tolerability of oral tranexamic acid when used as an adjunct to misoprostol for treatment of postpartum hemorrhage (PPH). Women will be diagnosed with postpartum hemorrhage if blood loss reaches 700ml in the calibrated receptacle. If diagnosed with postpartum hemorrhage , the woman will be randomized to receive either tranexamic acid or placebo, both in tablet form. All participants will receive 800 mcg sublingual misoprostol (4 tablets 200mcg each). The investigators hypothesize that tranexamic acid (in tablet form) as an adjunct to misoprostol will be more effective than misoprostol alone in stopping postpartum bleeding without recourse to further treatment in significantly more women.

Official 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

Conditions
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Postpartum Hemorrhage

Intervention / Treatment
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* Drug: Tranexamic Acid
* Drug: Placebo
* Drug: Misoprostol


Participation Criteria
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Eligibility 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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tranexamic acid<br>1950 mg oral tranexamic acid + 800 mcg sublingual misoprostol | Drug: Tranexamic Acid<br> <br> Drug: Misoprostol<br> <br> |
| Placebo Comparator: Placebo<br>oral placebo + 800 mcg sublingual misoprostol | Drug: Placebo<br> <br> Drug: Misoprostol<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of women with bleeding controlled with the study regimens alone, without recourse to further treatment in each study arm |  | 20 minutes after initial study treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of severe PPH | Rate of severe PPH (>1000 ml total blood loss) | 2 hours after delivery | 
| Mean/median blood loss |  | at two hours after treatment | 
| Proportion of women with controlled bleeding | proportion of women with bleeding controlled at different time intervals (20, 40, 60, 120 mins) | At various time intervals after study treatment (20, 40, 60, 120 mins) | 
| Use of uterotonic agents after initial treatment | Proportion of women who are given uterotonic agents after initial treatment | 2 hours after delivery | 
| Proportion of women who received a serious interventions | Serious intervention is defined as blood transfusion, interventions for tissue repair, surgical intervention [including curettage, vacuum aspiration for retained placental tissue, hysterectomy, surgical uterine artery ligature]) | 2 hours after delivery | 
| Proportion of women who received additional drugs | Proportion of women who receive additional drugs | 2 hours after delivery | 
| Proportion of women who receive additional intervention | Proportion of women who receive additional interventions (i.e. suturing) | 2 hours after delivery | 
| Adverse events | Proportion of women who experience an adverse event | 48 hours after delivery | 
| Proportion of women who experience side effects | Proportion of women who experience side effects | 2 hours after delivery | 
| Proportion of women who find the treatment tolerable | Proportion of women who find the procedure tolerable and acceptable as indicated in an acceptability scale | 48 hours after delivery |