Effectiveness of Tranexamic Acid When Used as an Adjunct to Misoprostol for the Treatment of Postpartum Hemorrhage
- Conditions
- Postpartum Hemorrhage
- Interventions
- Registration Number
- NCT02805426
- Lead Sponsor
- Gynuity Health Projects
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 260
- Women who delivery vaginally
- Women who experience PPH defined as blood loss ≥700ml
- Women capable of giving consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tranexamic acid Tranexamic Acid 1950 mg oral tranexamic acid + 800 mcg sublingual misoprostol Placebo Placebo oral placebo + 800 mcg sublingual misoprostol Tranexamic acid Misoprostol 1950 mg oral tranexamic acid + 800 mcg sublingual misoprostol Placebo Misoprostol oral placebo + 800 mcg sublingual misoprostol
- Primary Outcome Measures
Name Time Method 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
Name Time Method Mean/median blood loss at two hours after treatment Adverse events 48 hours after delivery Proportion of women who experience an adverse event
Proportion of women who experience side effects 2 hours after delivery Proportion of women who experience side effects
Proportion of women with controlled bleeding At various time intervals after study treatment (20, 40, 60, 120 mins) proportion of women with bleeding controlled at different time intervals (20, 40, 60, 120 mins)
Rate of severe PPH 2 hours after delivery Rate of severe PPH (\>1000 ml total blood loss)
Use of uterotonic agents after initial treatment 2 hours after delivery Proportion of women who are given uterotonic agents after initial treatment
Proportion of women who received a serious interventions 2 hours after delivery Serious intervention is defined as blood transfusion, interventions for tissue repair, surgical intervention \[including curettage, vacuum aspiration for retained placental tissue, hysterectomy, surgical uterine artery ligature\])
Proportion of women who received additional drugs 2 hours after delivery Proportion of women who receive additional drugs
Proportion of women who receive additional intervention 2 hours after delivery Proportion of women who receive additional interventions (i.e. suturing)
Proportion of women who find the treatment tolerable 48 hours after delivery Proportion of women who find the procedure tolerable and acceptable as indicated in an acceptability scale
Trial Locations
- Locations (4)
Hung Vuong Hospital
🇻🇳Ho Chi Minh City, Vietnam
Centre hospitalier Régional de Thiès, Ahmadou Sakhir Ndiéguène
🇸🇳Thiès, Senegal
National OB-GYN Hospital
🇻🇳Hanoi, Vietnam
Centre de santé 10ème de Thiès
🇸🇳Thiès, Senegal