NCT02688127

Brief Summary

This study evaluate role of tranexamic acid in reducing blood loss among pregnant women undergoing cesarean section because of placenta previa .Half of participants will receive tranexamia acid drug While the other half will receive placebo.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2015

Shorter than P25 for phase_1

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

February 17, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 23, 2016

Completed
Last Updated

February 23, 2016

Status Verified

February 1, 2016

Enrollment Period

6 months

First QC Date

February 17, 2016

Last Update Submit

February 17, 2016

Conditions

Postpartum Haemorrage Sever Bleeding After Delivery

Keywords

obstetric bleeding placenta previa

Outcome Measures

Primary Outcomes (1)

  • Amount of Actual blood loss in each group

    observational

    6hour after operation

Secondary Outcomes (1)

  • Difference in haemoglobin before operation and 24 hours after operation

    24 hours

Study Arms (2)

tranexamic acid group

EXPERIMENTAL

tranexamic acid given as 1 gram intravenous dose dilute in 500 cc of ringer lactate 20 minute before cesarean section

Drug: Tranexamic Acid

placebo group

PLACEBO COMPARATOR

the control group will receive 500 cc of ringer lactate 20 minute before cesarean section

Drug: Tranexamic Acid

Interventions

Tranexamic AcidDRUG

tranexamic acid or placebo are given before cesarean section in patient with placenta previa

Also known as: cyclo kapron
placebo grouptranexamic acid group

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • age 18 -38 Body mass index \<30 , Diagnosis of placenta previa

You may not qualify if:

  • patient with bleeding disorder , hepatic and renal disease. contraindication to tranexamic acid as allergy , hypersensitivity to tranexamic acid and known thromboembolic event during pregnancy .
  • other causes ofantepartum haemorrhage eg :accidental haemorrhage, rupture uterus.
  • type 1,2 of placenta previa anterior type 3,4 of placenta previa posterior causes of overdistended uterus like :multiple pregnancy, polyhydraminos

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Tranexamic Acid

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director , Clinical Research

Study Record Dates

First Submitted

February 17, 2016

First Posted

February 23, 2016

Study Start

August 1, 2015

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

February 23, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will share