Tranexamic Acid in Pregnant Women Undergoing Cesarean Section.

Not Applicable

Completed

• Conditions: Cesarean Section Complications
• Interventions: Drug: normal saline; Drug: Topical tranexamic acid

• Registration Number: NCT03778242
• Lead Sponsor: Aswan University Hospital

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2018-12-14
• Study First Submitted QC: 2018-12-14
• Study First Posted: 2018-12-19
• Study Start: 2019-01-01
• Primary Completion: 2022-03-30
• Study Completion: 2022-07-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-31
• Last Update Posted: 2023-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
normal saline	normal saline	temporary uterine packing with gauze of the dimensions soaked with 2 gm placebo to tranexamic diluted in 60ml saline acid
Topical tranexamic acid	Topical tranexamic acid	temporary uterine packing with gauze of the dimensions soaked with 2 gm tranexamic diluted in 60ml saline acid

Primary Outcome Measures

Name	Time	Method
number of patients need of additional pharmacological uterotonic	24 hours post operative	calculation number of patients need of additional pharmacological uterotonic

Secondary Outcome Measures

Name	Time	Method
amount of postoperative blood loss	4 hours postoperative	measure amount of blood loss post operative in ml by gravimetric methods
estimation of intraoperative blood loss (ml)	during the operation	measure Intraoperative blood loss in ml by gravimetric methods
number of patient with postpartum hemorrhage	24 hours post operative	calculation of the number of the patients with blood loss \>1000 ml

Trial Locations

Locations (1)

Aswan University; 🇪🇬 Aswan, Egypt