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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02688127
Recruitment Status : Completed
First Posted : February 23, 2016
Last Update Posted : February 23, 2016
Information provided by (Responsible Party):
shaimaa- sayed, Medical Research Council

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.

Condition or disease Intervention/treatment Phase
Postpartum Haemorrage Sever Bleeding After Delivery Drug: Tranexamic Acid Phase 1 Phase 2

Detailed Description:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy of Tranexamic Acid In Reducing Blood Loss Among Pregnant Women During Cesarean Section Because Of Placenta Previa
Study Start Date : August 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: tranexamic acid group
tranexamic acid given as 1 gram intravenous dose dilute in 500 cc of ringer lactate 20 minute before cesarean section
Drug: Tranexamic Acid
tranexamic acid or placebo are given before cesarean section in patient with placenta previa
Other Name: cyclo kapron

Placebo Comparator: placebo group
the control group will receive 500 cc of ringer lactate 20 minute before cesarean section
Drug: Tranexamic Acid
tranexamic acid or placebo are given before cesarean section in patient with placenta previa
Other Name: cyclo kapron

Primary Outcome Measures :
  1. Amount of Actual blood loss in each group [ Time Frame: 6hour after operation ]

Secondary Outcome Measures :
  1. Difference in haemoglobin before operation and 24 hours after operation [ Time Frame: 24 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

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Responsible Party: shaimaa- sayed, Director , Clinical Research, Medical Research Council Identifier: NCT02688127     History of Changes
Other Study ID Numbers: r22wa2xt
First Posted: February 23, 2016    Key Record Dates
Last Update Posted: February 23, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by shaimaa- sayed, Medical Research Council:
obstetric bleeding placenta previa
Additional relevant MeSH terms:
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Placenta Previa
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Placenta Diseases
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action