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

Postpartum Haemorrage Sever Bleeding After Delivery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02688127
• Other study ID #: r22wa2xt
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 17, 2016
• Last updated: February 17, 2016
• Start date: August 2015
• Est. completion date: February 2016

Study information

• Verified date: February 2016
• Source: Medical Research Council
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Placenta Previa
• Postpartum Haemorrage Sever Bleeding After Delivery

Intervention

Drug:
• Tranexamic Acid
tranexamic acid or placebo are given before cesarean section in patient with placenta previa

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical Research Council

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of Actual blood loss in each group	observational	6hour after operation	Yes
Secondary	Difference in haemoglobin before operation and 24 hours after operation	observational	24 hours	Yes