Efficacy of Tranexamic Acid In Reducing Blood Loss During Cesarean Section Because Of Placenta Previa

NCT ID: NCT02688127

Last Updated: 2016-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-02-29

Brief Summary

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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.

Detailed Description

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Tranexamic Acid used in the field of obstetrics to decrease blood loss during and after cesarean section .

Tranexamic Acid is an antifibrinolytic agent which cause reversible and competitive blockade of the lysine binding sites in plasminogen molecules . It is a synthetic analog of amino acid lysine and its action is to reduce blood loss

Conditions

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Postpartum Haemorrage Sever Bleeding After Delivery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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tranexamic acid group

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

Group Type EXPERIMENTAL

Tranexamic Acid

Intervention Type DRUG

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

placebo group

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

Group Type PLACEBO_COMPARATOR

Tranexamic Acid

Intervention Type DRUG

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

Interventions

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Tranexamic Acid

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

Intervention Type DRUG

Other Intervention Names

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cyclo kapron

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Medical Research Council

OTHER_GOV

Sponsor Role lead

Responsible Party

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shaimaa- sayed

Director , Clinical Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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r22wa2xt

Identifier Type: -

Identifier Source: org_study_id

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