Role of Tranexamic Acid Versus Uterine Cooling at Caesarean Section

September 1, 2016 updated by: Amro Mohamed Ibrahim Ibrahim Hetta, Talkha Central Hospital

Tranexamic Acid Versus Novel Uterine Cooling Technique in Reducing Blood Loss and Incidence of Postpartum Hemorrhage at Caesarean Section

This study aims to compare role of a prophylactic predefined intravenous Tranexamic Acid dose versus intraoperative Uterine Cooling in reducing blood loss and incidence of postpartum hemorrhage at secondary CS.

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, as an antifibrinolytic agent. 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.

A recent study by Mitchell et al. concluded that Uterine cooling during cesarean delivery was efficient enough to decrease blood loss and the incidence of postpartum hemorrhage.

This study aims to compare role of a prophylactic predefined intravenous Tranexamic Acid dose versus intraoperative Uterine Cooling in reducing blood loss and incidence of postpartum hemorrhage at secondary CS.

Study Type

Interventional

Enrollment (Actual)

100

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
    • Al-Dakahliya
      • Mansoura, Al-Dakahliya, Egypt, 35511
        • Talkha Central 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:

  • Women who attended Talkha Central Hospital for planned or emergency secondary CS.
  • Singleton pregnancy at term with gestational age (G.A) between 38±5 and 40 weeks.

Exclusion Criteria:

  • Preoperative exclusion criteria were women who had any disorders of heart, liver, kidney, brain or blood, Abruptio placenta, placental abnormalities or accrete syndromes, Polyhydramnios, macrosomia, preeclampsia, allergy to TXA, history of thromboembolic disorders, or severe anemia.
  • Intraoperative exclusion criteria was inability to exteriorize the uterus during CS for group (Y).

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group (X) Prophylactic Tranexamic Acid
Intravenously at 20 minutes preoperatively had an intervention of a single bolus TXA dose of 20•0 mg/kg, which was administered in Z solution (500•0 ml normal saline containing a prophylactic antibiotic 1•0 g) (NCT02739815).
Drug: Tranexamic Acid
At 20 minutes preoperatively, TXA of 20 mg/kg was administered in Z Solution (500•0 ml normal saline containing a prophylactic antibiotic 1•0 g).
Other Names:
  • TXA
Experimental: Group (Y) Intraoperative Uterine Cooling
Firstly intravenously at 20 minutes preoperatively had only the Z solution, and secondly [Intraoperatively immediately following delivery of the fetus the uterus was been externalized in the usual fashion, and the body of the uterus cephalad to the hysterotomy incision was been wrapped in sterile surgical towels saturated in sterile and iced normal saline. These towels came from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels was been kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen].
Procedure: Intraoperative Uterine Cooling
Intraoperatively immediately following delivery of the fetus the uterus was been externalized in the usual fashion, and the body of the uterus cephalad to the hysterotomy incision was been wrapped in sterile surgical towels saturated in sterile and iced normal saline. These towels came from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels was been kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total blood loss volume
Time Frame: Up to 3 hours
Estimation of Total Blood Loss Volume (ml) during CS and in the PACU.
Up to 3 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hematocrit value (Hct)
Time Frame: 6 hours postoperative period
Estimating change in Pre- versus Post-operative hematocrit values (%) at 6 hours postoperatively.
6 hours postoperative period
Overall blood loss volume greater than 1000 cc
Time Frame: Up to 9 hours
Estimation of overall blood loss volume during CS and up to 6 hours postoperatively
Up to 9 hours
Need for Additional Ecbolics
Time Frame: Intraoperative
Need for additional ecbolics to arrest and manage bleeding if there is a uterine atony
Intraoperative
Need for other surgical measures to stop bleeding
Time Frame: Intraoperative
Need for other surgical measures to stop bleeding (B-lynch denoting uterine atony, uterine artery ligation, hysterectomy)
Intraoperative
Transfusion of Blood or Blood Products
Time Frame: Up to 3 hours
Need for transfusion of blood or blood products during CS and in the PACU
Up to 3 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Pressure
Time Frame: Up to 3 hours
Measuring maternal blood pressure (mmHg) immediately postoperative and after 3 hours postoperative.
Up to 3 hours
Maternal Side effects of intervention administered
Time Frame: Up to 9 hours
Recording any Maternal side effects of interventions administered
Up to 9 hours
APGAR Scores
Time Frame: up to 2 hours
Recording of APGAR Score (/10) for all neonates immediately after delivery
up to 2 hours
Pulse Rate
Time Frame: Up to 3 hours
Measuring maternal pulse rate (/minute) immediately postoperative and after 3 hours postoperative.
Up to 3 hours

Collaborators and Investigators

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

Sponsor

Talkha Central Hospital

Investigators

  • Principal Investigator: Amro M Hetta, M.B., Ch.B., Talkha Central Hospital

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

June 1, 2016

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

May 19, 2016

First Submitted That Met QC Criteria

May 20, 2016

First Posted (Estimate)

May 23, 2016

Study Record Updates

Last Update Posted (Estimate)

September 5, 2016

Last Update Submitted That Met QC Criteria

September 1, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OG2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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