Topical Tranexamic Acid for the Prevention of Postpartum Hemorrhage in Women Undergoing Elective Cesarean Section

September 29, 2021 updated by: hany farouk, Aswan University Hospital

The Adjunctive Role of Temporary Uterine Packing Combined With Topical Tranexamic Acid for the Prevention of Postpartum Hemorrhage in Hypertensive Women Undergoing Elective Cesarean Section: A Randomized Controlled Trial

In hypertensive women having an elective 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

patients were allocated to one of two groups after induction of anesthesia. they received temporary uterine packing with gauze of the dimensions soaked with 2 gm tranexamic diluted in 60ml saline acid or placebo

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • hypertensive women undergoing elective cesarean section

Exclusion Criteria:

  • Patients with cardiac, hepatic, renal, or thromboembolic disease. ,
  • patients with the high possibility of the morbid adherent placenta,
  • known coagulopathy and
  • those presented with severe antepartum hemorrhage
  • refuse to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Topical tranexamic acid
temporary uterine packing with gauze of the dimensions soaked with 2 gm tranexamic diluted in 60ml saline acid or placebo
Drug: Topical tranexamic acid
temporary uterine packing with gauze of the dimensions soaked with 2 gm tranexamic diluted in 60ml saline acid
Other Names:
  • experimental
Placebo Comparator: normal saline
temporary uterine packing with gauze of the dimensions soaked with 2 gm placebo to tranexamic diluted in 60ml saline acid
Other: : normal saline
temporary uterine packing with gauze of the dimensions soaked with placebo to 2 gm tranexamic diluted in 60ml saline acid
Other Names:
  • Placebo Comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intraoperative blood loss
Time Frame: 30 minutes
measures the intraoperative blood loss by direct and gravimetric methods
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
need of blood transfusion
Time Frame: 12 hours
number of unites of blood transfusion
12 hours
need of uterotonic
Time Frame: 24 hours
misoprostol, oxytocin etc
24 hours
change in hemoglobin
Time Frame: 24 hours
change in hemoglobin
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aswan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2021

Primary Completion (Anticipated)

June 30, 2023

Study Completion (Anticipated)

September 30, 2023

Study Registration Dates

First Submitted

September 29, 2021

First Submitted That Met QC Criteria

September 29, 2021

First Posted (Actual)

October 11, 2021

Study Record Updates

Last Update Posted (Actual)

October 11, 2021

Last Update Submitted That Met QC Criteria

September 29, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • aswu/542/7/21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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