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Completed

NCT Number: NCT02805426

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

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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Key information

Conditions

Postpartum Hemorrhage Female Urogenital Diseases and Pregnancy Complications Hemorrhage Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Puerperal Disorders Urogenital Diseases Uterine Hemorrhage

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Centre de santé 10ème de Thiès, Thiès, Senegal

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tranexamic Acid

Drug

Placebo

Drug

Misoprostol

Drug

Primary outcomes

  1. 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

Secondary outcomes

  1. Rate of severe PPH

    Time frame: 2 hours after delivery

    Rate of severe PPH (>1000 ml total blood loss)

  2. Mean/median blood loss

    Time frame: at two hours after treatment

  3. Proportion of women with controlled bleeding

    Time frame: 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)

  4. Use of uterotonic agents after initial treatment

    Time frame: 2 hours after delivery

    Proportion of women who are given uterotonic agents after initial treatment

  5. Proportion of women who received a serious interventions

    Time frame: 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])

  6. Proportion of women who received additional drugs

    Time frame: 2 hours after delivery

    Proportion of women who receive additional drugs

  7. Proportion of women who receive additional intervention

    Time frame: 2 hours after delivery

    Proportion of women who receive additional interventions (i.e. suturing)

  8. Adverse events

    Time frame: 48 hours after delivery

    Proportion of women who experience an adverse event

  9. Proportion of women who experience side effects

    Time frame: 2 hours after delivery

    Proportion of women who experience side effects

  10. Proportion of women who find the treatment tolerable

    Time frame: 48 hours after delivery

    Proportion of women who find the procedure tolerable and acceptable as indicated in an acceptability scale

Sponsors and collaborators

Lead sponsor

Gynuity Health Projects

Other

Collaborators

  • Center for Research and Consultancy in Reproductive Health

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 20, 2016
Registry last updated
Feb 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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