Role Of Different Prophylactic Doses Of Intravenous Tranexamic Acid In Reducing Blood Loss At Caesarean Section

June 14, 2016 updated by: Amro Mohamed Ibrahim Ibrahim Hetta, Talkha Central Hospital

Comparative Study For Role Of Different Prophylactic Doses Of Intravenous Tranexamic Acid In Reducing Blood Loss At Caesarean Section: A Randomised Controlled Trial

This study aims to define a safe prophylactic intravenous TXA dose with an advantage over others in reducing total blood loss volume at secondary uncomplicated LSCS.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Bleeding during vaginal or operative delivery is always of prime concern. Despite significant progress in obstetric care 125,000 women die from obstetric hemorrhage annually in the world.

The incidence of CS is increasing, and the average blood loss during CS (1000 mL) is double the amount lost during vaginal delivery (500 mL). CS rate as high as 25-30% in many areas of the world. In Egypt the CS rate is 27.6 %, in United States of America, from 1970-2009 the CS rate rose from 4.5-32.9%, and declined to 32.8% of all deliveries at 2010. In spite of the various measures to prevent blood loss during and after CS, post-partum hemorrhage (PPH) continues to be the most common complication seen in almost 20% of the cases, and causes approximately 25% of maternal deaths worldwide, leading to increased maternal morbidity and mortality. Women who undergo a CS are much more likely to be delivered by a repeat operation in subsequent pregnancies. For women undergoing subsequent CS, the maternal risks are even greater like massive obstetric hemorrhage, hysterectomy, admission to an intensive care unit, or maternal death. Medications, such as oxytocin, misoprostol and prostaglandin F2α, have been used to control bleeding postoperatively.

TXA is a synthetic analog of the amino acid lysine,10 as an antifibrinolytic agent it has roughly eight times the antifibrinolytic activity of an older analogue; ε-aminocaproic acid. It competitively inhibits the activation of plasminogen to plasmin, by binding to specific sites of both plasminogen and plasmin, a molecule responsible for the degradation of fibrin, a protein that forms the framework of blood clots. Its intravenous administration has been routinely used for many years to reduce or prevent excessive hemorrhage in various medical conditions or disorders (helping hemostasis), also during and after surgical procedures like benign hysterectomy, open heart surgeries, scoliosis surgery, oral surgery, liver surgeries, total hip or knee arthroplasty, and urology. It has been shown to be very useful and efficient in reducing blood loss and incidence of blood transfusion in these surgeries, and decreases the risk of death in bleeding trauma patients. It was also included in the World Health Organization (WHO) Model List of Essential Medicines.

About its role in CS, some recent studies showed that TXA has advantage and useful effect safely in reducing blood loss and requirement of additional ecbolics. Its doses used intravenously to reduce blood loss at CS were a bolus of 1gm, 10 mg/kg, or 15 mg/kg which had an advantage over 10 mg/kg in anemic parturients. No defined safe prophylactic intravenous TXA dose being found in searching literature having an advantage over other doses in reducing total blood loss especially at secondary uncomplicated LSCS.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Al-Azhar University, Faculty of Medicine for Boys ( Cairo ), Al-Hussein University Hospital

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

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Maternal average age of 20-40 years.
  • Singleton pregnancy at term between 38±5 days and 40 weeks.
  • Elective planned or emergency secondary lower segment caesarean sections (LSCS).

Exclusion Criteria:

  • Women with severe medical and surgical complications as any of the following will be excluded :

    • Heart, liver, kidney, or brain diseases, and blood disorders.
    • Abruptio placenta, and placental abnormalities or accrete syndromes.
    • Polyhydramnios, macrosomia, preeclampsia, or allergy to tranexamic acid.
    • History of thromboembolic disorders, or severe anemia.

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Will receive a placebo (10 ml of distilled water) in Z solution [500 ml of normal saline containing a prophylactic Antibiotic 1 g] (At 20 minutes preoperatively).
Drug: Normal Saline containing a prophylactic Antibiotic 1 g
500 ml of normal saline containing a prophylactic Antibiotic 1 g.
Other Names:
  • Solution of Sodium Chloride 0.9 %
Active Comparator: T1
Will receive Tranexamic acid 15 mg/kg in Z solution [500 ml of normal saline containing a prophylactic Antibiotic 1 g] (At 20 minutes preoperatively).
Drug: Normal Saline containing a prophylactic Antibiotic 1 g
500 ml of normal saline containing a prophylactic Antibiotic 1 g.
Other Names:
  • Solution of Sodium Chloride 0.9 %
Drug: Tranexamic Acid
Tranexamic acid
Other Names:
  • TXA
Active Comparator: T2
Will receive Tranexamic acid 20 mg/kg in Z solution [500 ml of normal saline containing a prophylactic Antibiotic 1 g] (At 20 minutes preoperatively).
Drug: Normal Saline containing a prophylactic Antibiotic 1 g
500 ml of normal saline containing a prophylactic Antibiotic 1 g.
Other Names:
  • Solution of Sodium Chloride 0.9 %
Drug: Tranexamic Acid
Tranexamic acid
Other Names:
  • TXA
Active Comparator: T3
Will receive Tranexamic acid 25 mg/kg in Z solution [500 ml of normal saline containing a prophylactic Antibiotic 1 g] (At 20 minutes preoperatively).
Drug: Normal Saline containing a prophylactic Antibiotic 1 g
500 ml of normal saline containing a prophylactic Antibiotic 1 g.
Other Names:
  • Solution of Sodium Chloride 0.9 %
Drug: Tranexamic Acid
Tranexamic acid
Other Names:
  • TXA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Blood Loss Volume
Time Frame: Up to 7 hours
Estimating Total Blood Loss Volume (ml) during and after Caesarean Section, up to 6 hours post-operative.
Up to 7 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of surgery
Time Frame: Up to One hour
Duration of Caesarean Section estimating (min)
Up to One hour
Hemoglobin level (Hb)
Time Frame: 6 hours
6 hours post-operative hemoglobin level (mg/dL) estimating.
6 hours
Maternal weight (W)
Time Frame: 2 hours
2 hours post-operative maternal weight (kg) estimating
2 hours
Hematocrit value (Hct)
Time Frame: 6 hours
6 hours post-operative hematocrit value (%) estimating.
6 hours
Need for blood or blood products transfusion
Time Frame: Up to 6 hours
Need for other medical measures to arrest and manage bleeding (transfusion of blood or blood products)
Up to 6 hours
Need for additional ecbolics
Time Frame: Up to 6 hours
Need for other medical measures to arrest and manage bleeding if there is a uterine atony (more than five units of intravenous Syntocinon®)
Up to 6 hours
Need for hysterectomy
Time Frame: Up to 6 hours
Need for other surgical measures to arrest and manage bleeding (Hysterectomy)
Up to 6 hours
Need for uterine artery ligation
Time Frame: Up to 6 hours
Need for other surgical measures to arrest and manage bleeding (Uterine artery ligation)
Up to 6 hours
Need for B-lynch
Time Frame: Up to 6 hours
Need for other surgical measures to arrest and manage bleeding if there is a uterine atony (B-lynch)
Up to 6 hours
APGAR Score
Time Frame: Up to 30 minutes
APGAR Score as index for any neonatal side effects of medications given
Up to 30 minutes
Any sign for developing a thromboembolic disorder (Maternal)
Time Frame: One week
As index for any maternal side effects of medications given
One week
Blood pressure
Time Frame: Up to 2 hours
Measuring maternal blood pressure (mmHg) immediately postoperative and after 2 hours postoperative.
Up to 2 hours
Pulse rate
Time Frame: Up to 2 hours
Measuring maternal blood puse rate (/minute) immediately postoperative and after 2 hours postoperative.
Up to 2 hours

Collaborators and Investigators

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

Sponsor

Talkha Central Hospital

Collaborators

Al-Azhar University

Investigators

  • Principal Investigator: Amro M. Hetta, MS Student, Al-Azhar University, Faculty of Medicine for boys (Cairo), Departments of OBS/GYN
  • Study Director: Mahmoud E. Mohammed, Professor, Al-Azhar University, Faculty of Medicine for boys (Cairo), Departments of OBS/GYN
  • Study Chair: Yehia A. Wafa, Chairman, Al-Azhar University, Faculty of Medicine for boys (Cairo), Departments of OBS/GYN

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2016

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

April 4, 2016

First Submitted That Met QC Criteria

April 11, 2016

First Posted (Estimate)

April 15, 2016

Study Record Updates

Last Update Posted (Estimate)

June 15, 2016

Last Update Submitted That Met QC Criteria

June 14, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OG1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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