A Phase 4 interventional study of Tranexamic Acid and Placebo in Postpartum Hemorrhage, sponsored by Gynuity Health Projects. Completed at 4 sites in 2 countries. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-19.
Sponsored by Gynuity Health Projects · Phase 4, Interventional, and Treatment
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.
445 studies on the registry are indexed under Postpartum Hemorrhage; 75 are open to participants now.
This study's enrollment of 260 is above the median of 148 across 340 interventional studies indexed under Postpartum Hemorrhage.
Browse Postpartum Hemorrhage studies →Gynuity Health Projects is the lead sponsor of 112 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
1950 mg oral tranexamic acid + 800 mcg sublingual misoprostol
Drug: Tranexamic Acid · Drug: Misoprostol
oral placebo + 800 mcg sublingual misoprostol
Drug: Placebo · Drug: Misoprostol
Proportion of women with bleeding controlled with the study regimens alone, without recourse to further treatment in each study arm
Time frame: 20 minutes after initial study treatment
Rate of severe PPH
Rate of severe PPH (\>1000 ml total blood loss)
Time frame: 2 hours after delivery
Mean/median blood loss
Time frame: 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)
Time frame: 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
Time frame: 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 \[including curettage, vacuum aspiration for retained placental tissue, hysterectomy, surgical uterine artery ligature\])
Time frame: 2 hours after delivery
Proportion of women who received additional drugs
Proportion of women who receive additional drugs
Time frame: 2 hours after delivery
Proportion of women who receive additional intervention
Proportion of women who receive additional interventions (i.e. suturing)
Time frame: 2 hours after delivery
Adverse events
Proportion of women who experience an adverse event
Time frame: 48 hours after delivery
Proportion of women who experience side effects
Proportion of women who experience side effects
Time frame: 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
Time frame: 48 hours after delivery
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Gynuity Health Projects