Clinical trial NCT02805426: Effectiveness of Tranexamic Acid When Used as an Adjunct to Misoprostol for the Treatment of Postpartum Hemorrhage
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postpartum Hemorrhage
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
Collaborators: name: Center for Research and Consultancy in Reproductive Health
First posted: 2016-06-20
Enrollment: 260
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of women with bleeding controlled with the study regimens alone, without recourse to further treatment in each study arm
timeFrame: 20 minutes after initial study treatment
Secondary outcomes:
measure: Rate of severe PPH
timeFrame: 2 hours after delivery
measure: Mean/median blood loss
timeFrame: at two hours after treatment
measure: Proportion of women with controlled bleeding
timeFrame: At various time intervals after study treatment (20, 40, 60, 120 mins)
measure: Use of uterotonic agents after initial treatment
timeFrame: 2 hours after delivery
measure: Proportion of women who received a serious interventions
timeFrame: 2 hours after delivery
measure: Proportion of women who received additional drugs
timeFrame: 2 hours after delivery
measure: Proportion of women who receive additional intervention
timeFrame: 2 hours after delivery
measure: Adverse events
timeFrame: 48 hours after delivery
measure: Proportion of women who experience side effects
timeFrame: 2 hours after delivery
measure: Proportion of women who find the treatment tolerable
timeFrame: 48 hours after delivery
Other outcomes:
Locations:
city: Thiès
country: Senegal
facility: Centre de santé 10ème de Thiès
city: Thiès
country: Senegal
facility: Centre hospitalier Régional de Thiès, Ahmadou Sakhir Ndiéguène
city: Hanoi
country: Vietnam
facility: National OB-GYN Hospital
city: Ho Chi Minh City
country: Vietnam
facility: Hung Vuong Hospital
Study officials:
affiliation: Gynuity Health Projects
name: Beverly Winikoff, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Gynuity Health Projects
name: Jill Durocher
role: PRINCIPAL_INVESTIGATOR
affiliation: Gynuity Health Projects
name: Dina Abbas, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: CRCRH
name: Nguyen thi Nhu Ngoc, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Gynuity Health Projects
name: Ayisha Diop, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.