Postpartum Hemorrhage
Conditions
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.
Interventions
DRUGTranexamic Acid
DRUGPlacebo
DRUGMisoprostol
Sponsors
Center for Research and Consultancy in Reproductive Health
Gynuity Health Projects
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Mean/median blood loss | at two hours after treatment | — |
| 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) |
| 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 \[including curettage, vacuum aspiration for retained placental tissue, hysterectomy, surgical uterine artery ligature\]) |
| Rate of severe PPH | 2 hours after delivery | Rate of severe PPH (\>1000 ml total blood loss) |
| Proportion of women who receive additional intervention | 2 hours after delivery | Proportion of women who receive additional interventions (i.e. suturing) |
| 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 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 |
| Proportion of women who received additional drugs | 2 hours after delivery | Proportion of women who receive additional drugs |
Countries
Senegal, Vietnam
Outcome results
None listed