Tranexamic Acid in Preventing Postpartum Hemorrhage in High Risk Pregnancies During Elective Cesarean Section

Postpartum Hemorrhage Clinical Trial

Official title:

The Effect of Tranexamic Acid in Preventing Postpartum Hemorrhage in High Risk Pregnancies During Elective Cesarean Section, a Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03351686
• Other study ID #: MansuraU
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 20, 2017
• Last updated: November 22, 2017
• Start date: August 1, 2016
• Est. completion date: April 15, 2017

Study information

• Verified date: November 2017
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

postpartum hemorrhage (PPT) represents one of the major causes of maternal mortality . Tranexamic acid is used in many studies in management of PPH in combination with ecobolics. this study aims to evaluate the possible value of the use of tranexamic acid in prevention of postpartum hemorrhage .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: April 15, 2017
• Est. primary completion date: April 15, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 42 Years

Eligibility

Inclusion Criteria:

• Gestational age of 28 weeks or more.

• Chronic Hypertension.

• Preeclapmsia -Eclampsia.

• Multiple pregnancy.

• Uterine Liomyomas.

• Polyhydraminos.

• Fetal macrosomia.

• Associated Thrombocytopenia

• History of postpartum hemorrhage.

Exclusion Criteria:

• Patients with rheumatic heart disease.

• Patients with history Cardiac Valve Replacement.

• Current or past history of DVT.

• Women on any anticoagulant therapy.

• Sensitivity to tranexamic acid

• Pregnancies with any abnormally implanted or located placenta.

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage

Intervention

Drug:
• Tranexamic Acid
Tranexamic acid (Kepron, Amoun, Egypt) was given slowly intravenously over 10 minutes just before the skin incision of elective cesarean section to group A. Tranexamic acid injection was prepared by diluting 1g (10 mL) tranexamic acid into 20 ml of 5% glucose.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prevention of postpartum hemorrhage in high risk group	assessment of intraoperative blood loss	intraoperative