Topical Tranexamic Acid for the Prevention of Postpartum Hemorrhage in Women With Twin Pregnancy

Study Overview
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Brief Summary
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twin pregnant women requesting 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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The most common cause of postpartum hemorrhage (PPH) is uterine atony, which accounts for up to 80% of PPH occurrences. PPH is the main cause of maternal morbidity and mortality, accounting for up to 28% of all maternal deaths globally. As a result, generating a fast and efficient uterine contraction after birth is critical. Obesity, White or Hispanic race/ethnicity, polyhydramnios, preeclampsia, anemia, and chorioamnionitis, as well as a twin pregnancy, are all risk factors for uterine atony.

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 Women With Twin Pregnancy Undergoing 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: Women With Twin Pregnancy Undergoing Cesarean Section Exclusion Criteria: Patients with cardiac, hepatic, renal, or thromboembolic disease. , patients with a 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-blind randomized controlled study
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 | 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 2 gm placebo to 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 | measurement the intraoperative blood loss by direct and gravimetric methods | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative blood loss | measurement the intraoperative blood loss by direct and gravimetric methods | 12 hours | 
| need of blood transfusion | number of unites of blood transfusion | 24 hours | 
| need of uterotonic | misoprostol, oxytocin etc | 24 hours | 
| change in hemoglobin | change in hemoglobin | 24 hours |