Prevention of Postpartum Haemorrhage
Overview
Use of Tranexamic Acid for prevention of Postpartum hemorrhage in high risk patients: Randomized Control Trial
Full Title of Study: “Tranexamic Acid for the Prevention of Postpartum Haemorrhage”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Prevention
- Masking: None (Open Label)
- Study Primary Completion Date: April 2021
Detailed Description
This study aims to assess the efficacy of administration of Tranexamic Acid in preventing Postpartum haemorrhage & reducing intraoperative and postoperative blood loss in high risk women for Postpartum Hemorrhage undergoing caesarean section. Studying its benefit to transfusion-sparing and hysterectomy-sparing. & reduction of hemorrhage-related mortality when Postpartum hemorrhage is expected.
Interventions
- Drug: Tranexamic acid injection
- 1 gm (100 mg/ml) slowly intravenous infusion during delivery ( administered over 10 minutes at 1 ml/minute) .
Arms, Groups and Cohorts
- Active Comparator: Study
- Tranexamic acid 1 gm (100 mg/ml) slowly intravenous infusion during delivery ( administered over 10 minutes at 1 ml/minute) .
- No Intervention: Control
- control group will not be given tranexamic acid
Clinical Trial Outcome Measures
Primary Measures
- blood loss
- Time Frame: immediately after deliver
- Estimation of blood loss
Secondary Measures
- blood pressure
- Time Frame: immediately after delivery
- blood pressure
- pulse
- Time Frame: immediately after delivery
- pulse
- temperature
- Time Frame: immeditely after delivery
- temperature
Participating in This Clinical Trial
Inclusion Criteria
- Women at high risk for postpartum hemorrhage after cesarean section Exclusion Criteria:
- women who are not at high risk for postpartum hemorrhage , or attending for normal vaginal delivery.
Gender Eligibility: Female
Minimum Age: N/A
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Benha University
- Provider of Information About this Clinical Study
- Principal Investigator: Dr. Abou Bakr Mohamed El Nashaar, professor – Benha University
- Overall Official(s)
- Shaimaa Ezzat, Principal Investigator, Police Hospital
- Overall Contact(s)
- Aboubakr Elnashar, MD, 00201066934749, elnashar53@hotmail.com
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