NCT02805426

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
260

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2016

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 20, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

February 19, 2018

Status Verified

February 1, 2018

Enrollment Period

1.3 years

First QC Date

March 9, 2016

Last Update Submit

February 15, 2018

Conditions

Postpartum Hemorrhage

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Rate of severe PPH

    2 hours after delivery

  • 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)

  • Use of uterotonic agents after initial treatment

    2 hours after delivery

  • Proportion of women who received a serious interventions

    2 hours after delivery

  • +5 more secondary outcomes

Study Arms (2)

Tranexamic acid

EXPERIMENTAL

1950 mg oral tranexamic acid + 800 mcg sublingual misoprostol

Drug: Tranexamic AcidDrug: Misoprostol

Placebo

PLACEBO COMPARATOR

oral placebo + 800 mcg sublingual misoprostol

Drug: PlaceboDrug: Misoprostol

Interventions

Tranexamic AcidDRUG
Tranexamic acid
PlaceboDRUG
Placebo
MisoprostolDRUG
PlaceboTranexamic acid

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Women who delivery vaginally
  • Women who experience PPH defined as blood loss ≥700ml
  • Women capable of giving consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Centre de santé 10ème de Thiès

Thiès, Senegal

Location

Centre hospitalier Régional de Thiès, Ahmadou Sakhir Ndiéguène

Thiès, Senegal

Location

National OB-GYN Hospital

Hanoi, Vietnam

Location

Hung Vuong Hospital

Ho Chi Minh City, Vietnam

Location

Related Publications (1)

  • 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.

    PMID: 32143721DERIVED

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Tranexamic AcidMisoprostol

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsProstaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2016

First Posted

June 20, 2016

Study Start

October 1, 2016

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

February 19, 2018

Record last verified: 2018-02

Locations

VN(2)SE(2)