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

Postpartum Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02805426
• Other study ID #: 3006
• Status: Completed
• Phase: Phase 4
• First received: March 9, 2016
• Last updated: February 15, 2018
• Start date: October 2016
• Est. completion date: January 2018

Study information

• Verified date: February 2018
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage

Intervention

Drug:
• Tranexamic Acid

• Placebo

• Misoprostol

Locations

Country	Name	City	State
Senegal	Centre de santé 10ème de Thiès	Thiès
Senegal	Centre hospitalier Régional de Thiès, Ahmadou Sakhir Ndiéguène	Thiès
Vietnam	National OB-GYN Hospital	Hanoi
Vietnam	Hung Vuong Hospital	Ho Chi Minh City

Sponsors (2)

Lead Sponsor	Collaborator
Gynuity Health Projects	Center for Research and Consultancy in Reproductive Health

Countries where clinical trial is conducted

Senegal,  Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of severe PPH	Rate of severe PPH (>1000 ml total blood loss)	2 hours after delivery
Secondary	Mean/median blood loss		at two hours after treatment
Secondary	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)
Secondary	Use of uterotonic agents after initial treatment	Proportion of women who are given uterotonic agents after initial treatment	2 hours after delivery
Secondary	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
Secondary	Proportion of women who received additional drugs	Proportion of women who receive additional drugs	2 hours after delivery
Secondary	Proportion of women who receive additional intervention	Proportion of women who receive additional interventions (i.e. suturing)	2 hours after delivery
Secondary	Adverse events	Proportion of women who experience an adverse event	48 hours after delivery
Secondary	Proportion of women who experience side effects	Proportion of women who experience side effects	2 hours after delivery
Secondary	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