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

Gynuity Health Projects

Status and phase: Completed; Phase 4

Conditions: Postpartum Hemorrhage

Treatments: Drug: Placebo; Drug: Tranexamic Acid; Drug: Misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT02805426

3006

Details and patient eligibility

About

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.

Enrollment: 260 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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260 participants in 2 patient groups, including a placebo group

Tranexamic acid

Experimental group

Description:

1950 mg oral tranexamic acid + 800 mcg sublingual misoprostol

Treatment:

Drug: Misoprostol

Drug: Tranexamic Acid

Placebo

Placebo Comparator group

Description:

oral placebo + 800 mcg sublingual misoprostol

Treatment:

Drug: Misoprostol

Drug: Placebo