NCT04463966

Brief Summary

Use of Tranexamic Acid for prevention of Postpartum hemorrhage in high risk patients: Randomized Control Trial

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

April 30, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

April 30, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 9, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

July 9, 2020

Status Verified

July 1, 2020

Enrollment Period

11 months

First QC Date

April 30, 2020

Last Update Submit

July 8, 2020

Conditions

Post Partum Hemorrhage

Keywords

tranexamic acidpostpartum hemorrhagecesarean section

Outcome Measures

Primary Outcomes (1)

  • blood loss

    Estimation of blood loss

    immediately after deliver

Secondary Outcomes (3)

  • blood pressure

    immediately after delivery

  • pulse

    immediately after delivery

  • temperature

    immeditely after delivery

Study Arms (2)

Study

ACTIVE COMPARATOR

Tranexamic acid 1 gm (100 mg/ml) slowly intravenous infusion during delivery ( administered over 10 minutes at 1 ml/minute) .

Drug: Tranexamic acid injection

Control

NO INTERVENTION

control group will not be given tranexamic acid

Interventions

Tranexamic acid injectionDRUG

1 gm (100 mg/ml) slowly intravenous infusion during delivery ( administered over 10 minutes at 1 ml/minute) .

Also known as: Kapron, 500 mg/5ml
Study

Eligibility Criteria

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

You may qualify if:

  • Women at high risk for postpartum hemorrhage after cesarean section

You may not qualify if:

  • women who are not at high risk for postpartum hemorrhage , or attending for normal vaginal delivery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Police Hospital

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Tranexamic Acid

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 Chemicals

Study Officials

  • Shaimaa Ezzat

    Police Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aboubakr Elnashar, MD

CONTACT

00201066934749elnashar53@hotmail.com

shaimaa ezzat

CONTACT

00201009023289

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

April 30, 2020

First Posted

July 9, 2020

Study Start

April 30, 2020

Primary Completion

April 1, 2021

Study Completion

May 1, 2021

Last Updated

July 9, 2020

Record last verified: 2020-07

Locations

EG(1)