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NCT05072860 Clinical Trial

Topical Tranexamic Acid for the Prevention of Postpartum Hemorrhage in Women Undergoing Elective Cesarean Section

Cesarean Section Complications Clinical Trial

Official title:
The Adjunctive Role of Temporary Uterine Packing Combined With Topical Tranexamic Acid for the Prevention of Postpartum Hemorrhage in Hypertensive Women Undergoing Elective Cesarean Section: A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05072860
Other study ID # aswu/542/7/21
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 1, 2021
Est. completion date September 30, 2023

Study information
Verified date September 2021
Source Aswan University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In hypertensive women having an elective cesarean section, the effectiveness and safety of temporary uterine packing coupled with topical tranexamic acid as an adjuvant for decreasing blood loss during delivery were compared to placebo.

Description:

patients were allocated to one of two groups after induction of anesthesia. they received temporary uterine packing with gauze of the dimensions soaked with 2 gm tranexamic diluted in 60ml saline acid or placebo

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 150
Est. completion date September 30, 2023
Est. primary completion date June 30, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - hypertensive women undergoing elective cesarean section Exclusion Criteria: - Patients with cardiac, hepatic, renal, or thromboembolic disease. , - patients with the high possibility of the morbid adherent placenta, - known coagulopathy and - those presented with severe antepartum hemorrhage - refuse to participate

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Topical tranexamic acid
temporary uterine packing with gauze of the dimensions soaked with 2 gm tranexamic diluted in 60ml saline acid
Other:
• : normal saline
temporary uterine packing with gauze of the dimensions soaked with placebo to 2 gm tranexamic diluted in 60ml saline acid

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Aswan University Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary intraoperative blood loss measures the intraoperative blood loss by direct and gravimetric methods 30 minutes
Secondary need of blood transfusion number of unites of blood transfusion 12 hours
Secondary need of uterotonic misoprostol, oxytocin etc 24 hours
Secondary change in hemoglobin change in hemoglobin 24 hours
See also
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