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Role of Tranexamic Acid Versus Uterine Cooling at Caesarean Section

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02780245
First Posted: May 23, 2016
Last Update Posted: September 5, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Amro Mohamed Ibrahim Ibrahim Hetta, Talkha Central Hospital
  Purpose
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.

Condition Intervention Phase
Hemorrhage of Cesarean Section and/or Perineal Wound Postpartum Hemorrhage Uterine Atony Drug: Tranexamic Acid Procedure: Intraoperative Uterine Cooling Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Tranexamic Acid Versus Novel Uterine Cooling Technique in Reducing Blood Loss and Incidence of Postpartum Hemorrhage at Caesarean Section

Resource links provided by NLM:


Further study details as provided by Amro Mohamed Ibrahim Ibrahim Hetta, Talkha Central Hospital:

Primary Outcome Measures:
  • Total blood loss volume [ Time Frame: Up to 3 hours ]
    Estimation of Total Blood Loss Volume (ml) during CS and in the PACU.


Secondary Outcome Measures:
  • Hematocrit value (Hct) [ Time Frame: 6 hours postoperative period ]
    Estimating change in Pre- versus Post-operative hematocrit values (%) at 6 hours postoperatively.

  • 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

  • Need for Additional Ecbolics [ Time Frame: Intraoperative ]
    Need for additional ecbolics to arrest and manage bleeding if there is a uterine atony

  • 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)

  • 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


Other Outcome Measures:
  • Blood Pressure [ Time Frame: Up to 3 hours ]
    Measuring maternal blood pressure (mmHg) immediately postoperative and after 3 hours postoperative.

  • Maternal Side effects of intervention administered [ Time Frame: Up to 9 hours ]
    Recording any Maternal side effects of interventions administered

  • APGAR Scores [ Time Frame: up to 2 hours ]
    Recording of APGAR Score (/10) for all neonates immediately after delivery

  • Pulse Rate [ Time Frame: Up to 3 hours ]
    Measuring maternal pulse rate (/minute) immediately postoperative and after 3 hours postoperative.


Enrollment: 100
Study Start Date: June 2016
Study Completion Date: September 2016
Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02780245


Locations
Egypt
Talkha Central Hospital
Mansoura, Al-Dakahliya, Egypt, 35511
Sponsors and Collaborators
Talkha Central Hospital
Investigators
Principal Investigator: Amro M Hetta, M.B., Ch.B. Talkha Central Hospital
  More Information

Publications:
Tarabrin O, Kaminskiy V, Galich S, Tkachenko R, Gulyaev A, Shcherbakov S, et al. Efficacy of tranexamic acid in decreasing blood loss during cesarean section. Critical Care 2012, 16(1): 1-189.
Gibbons L, Belizán JM, Lauer JA, Betrán AP, Merialdi M, Althabe F. The global numbers and costs of additionally needed and unnecessary caesarean sections performed per year: overuse as a barrier to universal coverage. World health report 2010, 30: 1-31.
Mayur G, Purvi P, Ashoo G, Pankaj D. Efficacy of tranexamic acid in decreasing blood loss during and after cesarean section: a randomized case controlled prospective study. J Obstet Gynecol India 2007, 57(3): 4.
Yehia AH, Koleib MH, Abdelazim IA, Atik A. Tranexamic acid reduces blood loss during and after cesarean section: A double blinded, randomized, controlled trial. Asian Pacific Journal of Reproduction 2014, 3(1): 53-56.
Gupta A, Dwivedi Y, Shakya V, Srivastva U, Saxena A, Agarwal AM, et al. Efficacy of Tranexamic Acid in Reducing Perioperative Blood Loss During Caesarean Section: A Placebo Controlled Double Blind Study. International Journal of Scientific Research 2016, 5(3).
Mitchell JL, Stecher J, Crowson J, Rich D. Uterine Cooling During Cesarean Delivery to Reduce Blood Loss and Incidence of Postpartum Hemorrhage: A Randomized Controlled Trial [31]. Obstetrics & Gynecology. 2015 May 1;125:9S-10S.

Responsible Party: Amro Mohamed Ibrahim Ibrahim Hetta, Dr. Amro M. Hetta, Talkha Central Hospital
ClinicalTrials.gov Identifier: NCT02780245     History of Changes
Other Study ID Numbers: OG2
First Submitted: May 19, 2016
First Posted: May 23, 2016
Last Update Posted: September 5, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Amro Mohamed Ibrahim Ibrahim Hetta, Talkha Central Hospital:
Caesarean Section
Tranexamic Acid
Postpartum Hemorrhage
Ecbolics

Additional relevant MeSH terms:
Hemorrhage
Postpartum Hemorrhage
Uterine Inertia
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Dystocia
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants