Tranexamic Acid in Pregnant Women Undergoing Cesarean Section.

Cesarean Section Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03778242
• Other study ID #: aswu/276/18
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: July 1, 2022

Study information

• Verified date: March 2023
• Source: Aswan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: July 1, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section Complications

Intervention

Drug:
• Topical tranexamic acid
temporary uterine packing with gauze of the dimensions soaked with 2 gm tranexamic diluted in 60ml saline acid
• normal saline
2 placebo ampoules to TA in 100 ml saline by slow infusion

Locations

Country	Name	City	State
Egypt	Aswan University	Aswan

Sponsors (1)

Lead Sponsor	Collaborator
Aswan University Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of patients need of additional pharmacological uterotonic	calculation number of patients need of additional pharmacological uterotonic	24 hours post operative
Secondary	estimation of intraoperative blood loss (ml)	measure Intraoperative blood loss in ml by gravimetric methods	during the operation
Secondary	amount of postoperative blood loss	measure amount of blood loss post operative in ml by gravimetric methods	4 hours postoperative
Secondary	number of patient with postpartum hemorrhage	calculation of the number of the patients with blood loss >1000 ml	24 hours post operative