NCT03778242

Brief Summary

Purpose to evaluate the effects of topical tranexamic acid (TA) on reducing post-partum hemorrhage in pregnant women with hemorrhagic cesarean section

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

December 14, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 19, 2018

Completed
13 days until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

April 4, 2023

Status Verified

March 1, 2023

Enrollment Period

3.2 years

First QC Date

December 14, 2018

Last Update Submit

March 31, 2023

Conditions

Cesarean Section Complications

Keywords

cesarean sectiontranexamic acidpostpartum hemorrhageoxytocin

Outcome Measures

Primary Outcomes (1)

  • number of patients need of additional pharmacological uterotonic

    calculation number of patients need of additional pharmacological uterotonic

    24 hours post operative

Secondary Outcomes (3)

  • estimation of intraoperative blood loss (ml)

    during the operation

  • amount of postoperative blood loss

    4 hours postoperative

  • number of patient with postpartum hemorrhage

    24 hours post operative

Study Arms (2)

Topical tranexamic acid

ACTIVE COMPARATOR

temporary uterine packing with gauze of the dimensions soaked with 2 gm tranexamic diluted in 60ml saline acid

Drug: Topical tranexamic acid

normal saline

PLACEBO COMPARATOR

temporary uterine packing with gauze of the dimensions soaked with 2 gm placebo to tranexamic diluted in 60ml saline acid

Drug: normal saline

Interventions

Topical tranexamic acidDRUG

temporary uterine packing with gauze of the dimensions soaked with 2 gm tranexamic diluted in 60ml saline acid

Also known as: Active Comparator
Topical tranexamic acid
normal salineDRUG

2 placebo ampoules to TA in 100 ml saline by slow infusion

Also known as: Placebo comparator
normal saline

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspatients who were admitted for an elective or non-emergency CS during labor and exposed to intraoperative bleeding about 800 ml
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • patients who were admitted for an elective or non-emergency CS during labor and exposed to intraoperative bleeding about 800 ml

You may not qualify if:

  • placenta praevia and placental abruption
  • Women with a medical disorder,
  • placenta accrete,
  • allergy to TA, and
  • intraoperative bleeding thanks to causes aside from uterine atony
  • Patients over 40 or who have
  • pre-existing coagulation disorders,
  • with a severe medical disorder
  • allergy to tranexamic acid
  • refuse to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aswan University

Aswān, 81528, Egypt

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Tranexamic AcidSaline Solution

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 ChemicalsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • hany f sallam, md

    Aswan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
open label Randomized Clinical Tria
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: open label Randomized Clinical Tria
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 14, 2018

First Posted

December 19, 2018

Study Start

January 1, 2019

Primary Completion

March 30, 2022

Study Completion

July 1, 2022

Last Updated

April 4, 2023

Record last verified: 2023-03

Locations

EG(1)