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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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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

Conditions
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Cesarean Section Complications

Intervention / Treatment
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* Drug: Topical tranexamic acid
* Other: : normal saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: a double-blinded randomized controlled trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Topical tranexamic acid<br>temporary uterine packing with gauze of the dimensions soaked with 2 gm tranexamic diluted in 60ml saline acid or placebo | Drug: Topical tranexamic acid<br>* temporary uterine packing with gauze of the dimensions soaked with 2 gm tranexamic diluted in 60ml saline acid<br>* Other names: experimental;|
| Placebo Comparator: normal saline<br>temporary uterine packing with gauze of the dimensions soaked with 2 gm placebo to tranexamic diluted in 60ml saline acid | Other: : normal saline<br>* temporary uterine packing with gauze of the dimensions soaked with placebo to 2 gm tranexamic diluted in 60ml saline acid<br>* Other names: Placebo Comparator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraoperative blood loss | measures the intraoperative blood loss by direct and gravimetric methods | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| need of blood transfusion | number of unites of blood transfusion | 12 hours | 
| need of uterotonic | misoprostol, oxytocin etc | 24 hours | 
| change in hemoglobin | change in hemoglobin | 24 hours |