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

Phase 1

Completed

• Conditions: Postpartum Haemorrage Sever Bleeding After Delivery
• Interventions: Drug: Tranexamic Acid

• Registration Number: NCT02688127
• Lead Sponsor: 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.

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

Study Timeline

• Study Start: 2015-08
• Status Verified: 2016-02
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Study First Submitted: 2016-02-17
• Study First Submitted QC: 2016-02-17
• Last Update Submitted: 2016-02-17
• Study First Posted: 2016-02-23
• Last Update Posted: 2016-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tranexamic acid group	Tranexamic Acid	tranexamic acid given as 1 gram intravenous dose dilute in 500 cc of ringer lactate 20 minute before cesarean section
placebo group	Tranexamic Acid	the control group will receive 500 cc of ringer lactate 20 minute before cesarean section

Primary Outcome Measures

Name	Time	Method
Amount of Actual blood loss in each group	6hour after operation	observational

Secondary Outcome Measures

Name	Time	Method
Difference in haemoglobin before operation and 24 hours after operation	24 hours	observational