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NCT03351686 Clinical Trial

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
Secondary ID
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
Health authority
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.

Study Design

Related Conditions & MeSH terms

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
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