NCT03351686

Brief Summary

postpartum hemorrhage (PPT) represents one of the major causes of maternal mortality . Tranexamic acid is used in many studies in management of PPH in combination with ecobolics. this study aims to evaluate the possible value of the use of tranexamic acid in prevention of postpartum hemorrhage .

Trial Health

100
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2016

Shorter than P25 for phase_2

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

Study Start

First participant enrolled

August 1, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 24, 2017

Completed
Last Updated

November 27, 2017

Status Verified

November 1, 2017

Enrollment Period

9 months

First QC Date

November 20, 2017

Last Update Submit

November 22, 2017

Conditions

Postpartum Hemorrhage

Keywords

tranexamic acid

Outcome Measures

Primary Outcomes (1)

  • prevention of postpartum hemorrhage in high risk group

    assessment of intraoperative blood loss

    intraoperative

Study Arms (2)

tranexamic acid group

EXPERIMENTAL
Drug: Tranexamic Acid

non tranexamic (control) group

NO INTERVENTION

Interventions

Tranexamic AcidDRUG

Tranexamic acid (Kepron, Amoun, Egypt) was given slowly intravenously over 10 minutes just before the skin incision of elective cesarean section to group A. Tranexamic acid injection was prepared by diluting 1g (10 mL) tranexamic acid into 20 ml of 5% glucose.

tranexamic acid group

Eligibility Criteria

Age20 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Gestational age of 28 weeks or more.
  • Chronic Hypertension.
  • Preeclapmsia -Eclampsia.
  • Multiple pregnancy.
  • Uterine Liomyomas.
  • Polyhydraminos.
  • Fetal macrosomia.
  • Associated Thrombocytopenia
  • History of postpartum hemorrhage.

You may not qualify if:

  • Patients with rheumatic heart disease.
  • Patients with history Cardiac Valve Replacement.
  • Current or past history of DVT.
  • Women on any anticoagulant therapy.
  • Sensitivity to tranexamic acid
  • Pregnancies with any abnormally implanted or located placenta.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

  • Hanan Nabil, MD

    Mansoura University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 20, 2017

First Posted

November 24, 2017

Study Start

August 1, 2016

Primary Completion

April 15, 2017

Study Completion

April 15, 2017

Last Updated

November 27, 2017

Record last verified: 2017-11