Tranexamic Acid in Pregnant Women Undergoing Cesarean Section.

Study Overview
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Brief Summary
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Purpose to evaluate the effects of topical tranexamic acid (TA) on reducing post-partum hemorrhage in pregnant women with hemorrhagic cesarean section

Detailed Description
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Uterine atony is the major cause of postpartum hemorrhage (PPH), accounting for up to 80% of PPH cases. PPH is the leading cause of maternal morbidity and mortality worldwide, resulting in up to 28% of maternal deaths. Therefore, inducing a rapid and effective uterine contraction following delivery is an important issue. The aim of the study is to To explore the efficacy and safety of temporary uterine packing combined with topical tranexamic acid (TA) as an adjunct for reducing blood loss during a hemorrhagic cesarean delivery (CD), compared with placebo.

Official Title
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The Adjunctive Role of Temporary Uterine Packing Combined With Topical Tranexamic Acid for Reducing Blood Loss During Hemorrhagic Cesarean Delivery: A Randomized Controlled Trial

Conditions
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Cesarean Section Complications

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients who were admitted for an elective or non-emergency CS during labor and exposed to intraoperative bleeding about 800 ml Exclusion Criteria: placenta praevia and placental abruption Women with a medical disorder, placenta accrete, allergy to TA, and intraoperative bleeding thanks to causes aside from uterine atony Patients over 40 or who have pre-existing coagulation disorders, with a severe medical disorder allergy to tranexamic acid refuse to consent

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: open label Randomized Clinical Tria
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Topical tranexamic acid<br>temporary uterine packing with gauze of the dimensions soaked with 2 gm tranexamic diluted in 60ml saline acid | 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: Active Comparator;|
| 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 | Drug: normal saline<br>* 2 placebo ampoules to TA in 100 ml saline by slow infusion<br>* Other names: Placebo comparator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients need of additional pharmacological uterotonic | calculation number of patients need of additional pharmacological uterotonic | 24 hours post operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| estimation of intraoperative blood loss (ml) | measure Intraoperative blood loss in ml by gravimetric methods | during the operation | 
| amount of postoperative blood loss | measure amount of blood loss post operative in ml by gravimetric methods | 4 hours postoperative | 
| number of patient with postpartum hemorrhage | calculation of the number of the patients with blood loss >1000 ml | 24 hours post operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cesarean section, tranexamic acid, postpartum hemorrhage, oxytocin