Tranexamic Acid in Pregnant Women Undergoing Cesarean Section.

NCT ID: NCT03778242

Last Updated: 2023-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2022-07-01

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.

Conditions

Cesarean Section Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Topical tranexamic acid

temporary uterine packing with gauze of the dimensions soaked with 2 gm tranexamic diluted in 60ml saline acid

Group Type: ACTIVE_COMPARATOR

Topical tranexamic acid

Intervention Type: DRUG

temporary uterine packing with gauze of the dimensions soaked with 2 gm tranexamic diluted in 60ml saline acid

normal saline

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

Group Type: PLACEBO_COMPARATOR

normal saline

Intervention Type: DRUG

2 placebo ampoules to TA in 100 ml saline by slow infusion

Interventions

Topical tranexamic acid

temporary uterine packing with gauze of the dimensions soaked with 2 gm tranexamic diluted in 60ml saline acid

Intervention Type: DRUG

normal saline

2 placebo ampoules to TA in 100 ml saline by slow infusion

Intervention Type: DRUG

Other Intervention Names

Active Comparator; Placebo comparator

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Aswan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

hany farouk

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

hany f sallam, md

Role: PRINCIPAL_INVESTIGATOR

Aswan University Hospital

Locations

Aswan University

Aswān, , Egypt

Countries

Egypt

Other Identifiers

aswu/276/18

Identifier Type: -

Identifier Source: org_study_id