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Clinical trial

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

ID
Name
aswu/276/18
Description
Purpose to evaluate the effects of topical tranexamic acid (TA) on reducing post-partum hemorrhage in pregnant women with hemorrhagic cesarean section
Trial arms
Trial start
2019-01-01
Estimated PCD
2022-03-30
Trial end
2022-07-01
Status
Completed
Treatment
Topical tranexamic acid
temporary uterine packing with gauze of the dimensions soaked with 2 gm tranexamic diluted in 60ml saline acid
Arms:
Topical tranexamic acid
Other names:
Active Comparator
normal saline
2 placebo ampoules to TA in 100 ml saline by slow infusion
Arms:
normal saline
Other names:
Placebo comparator
Size
180
Primary endpoint
number of patients need of additional pharmacological uterotonic
24 hours post operative
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'open label Randomized Clinical Tria', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'open label Randomized Clinical Tria'}}, 'enrollmentInfo': {'count': 180, 'type': 'ACTUAL'}}
Updated at
2023-04-04

1 organization

1 product

1 drug

1 indication

Organization
Aswan University Hospital
Product
Tranexamic acid
Indication
Cesarean Section Complications
Drug
Varlilumab