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| Name | Class |
|---|---|
| Center for Research and Consultancy in Reproductive Health | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tranexamic acid | Experimental | 1950 mg oral tranexamic acid + 800 mcg sublingual misoprostol |
|
| Placebo | Placebo Comparator | oral placebo + 800 mcg sublingual misoprostol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | Drug |
| ||
| Placebo |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of severe PPH | Rate of severe PPH (>1000 ml total blood loss) | 2 hours after delivery |
| Mean/median blood loss | at two hours after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beverly Winikoff, MD, MPH | Gynuity Health Projects | Principal Investigator |
| Jill Durocher | Gynuity Health Projects | Principal Investigator |
| Dina Abbas, MPH | Gynuity Health Projects | Principal Investigator |
| Nguyen thi Nhu Ngoc, MD, MSc | CRCRH | Principal Investigator |
| Ayisha Diop, MPH | Gynuity Health Projects | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de santé 10ème de Thiès | Thiès | Senegal | ||||
| Centre hospitalier Régional de Thiès, Ahmadou Sakhir Ndiéguène |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32143721 | Derived | Diop A, Abbas D, Ngoc NTN, Martin R, Razafi A, Tuyet HTD, Winikoff B. A double-blind, randomized controlled trial to explore oral tranexamic acid as adjunct for the treatment for postpartum hemorrhage. Reprod Health. 2020 Mar 6;17(1):34. doi: 10.1186/s12978-020-0887-2. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 30, 2018 | |
| Reset | Feb 8, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 30, 2018 | Feb 8, 2019 |
| ID | Term |
|---|---|
| D006473 | Postpartum Hemorrhage |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D016595 | Misoprostol |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| Misoprostol | Drug |
|
| 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) |
| Use of uterotonic agents after initial treatment | Proportion of women who are given uterotonic agents after initial treatment | 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]) | 2 hours after delivery |
| Proportion of women who received additional drugs | Proportion of women who receive additional drugs | 2 hours after delivery |
| Proportion of women who receive additional intervention | Proportion of women who receive additional interventions (i.e. suturing) | 2 hours after delivery |
| Adverse events | Proportion of women who experience an adverse event | 48 hours after delivery |
| Proportion of women who experience side effects | Proportion of women who experience side effects | 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 | 48 hours after delivery |
| Thiès |
| Senegal |
| National OB-GYN Hospital | Hanoi | Vietnam |
| Hung Vuong Hospital | Ho Chi Minh City | Vietnam |
| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011459 |
| Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |