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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2018-01-31

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.

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Detailed Description

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Conditions

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Postpartum Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Tranexamic acid

1950 mg oral tranexamic acid + 800 mcg sublingual misoprostol

Group Type EXPERIMENTAL

Tranexamic Acid

Intervention Type DRUG

Misoprostol

Intervention Type DRUG

Placebo

oral placebo + 800 mcg sublingual misoprostol

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Misoprostol

Intervention Type DRUG

Interventions

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Tranexamic Acid

Intervention Type DRUG

Placebo

Intervention Type DRUG

Misoprostol

Intervention Type DRUG

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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes