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The Value of Tranxemic Acid to Reduce Intraoperative Blood Loss During Elective Cesarean Sections in High Risk Women

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.
 
ClinicalTrials.gov Identifier: NCT03820206
Recruitment Status : Completed
First Posted : January 29, 2019
Last Update Posted : January 6, 2020
Sponsor:
Information provided by (Responsible Party):
Ahmed M Maged, MD, Cairo University

Brief Summary:

A full medical history will be obtained from all participants. Obstetric ultrasonography and laboratory tests will be performed.According to group assignment, either 1 g(10 mL) tranexamic acid stored in a dry container at 15 °C-30 °C) diluted in 20 mL of 5% glucose or 30 mL of 5% glucose will be slowly administered intravenously 15 minutes before skin incision over a 5-minute period.

Following delivery, patients in both groups will receive an intravenous bolus of 5 IU oxytocin , 1 mL(0.2 mg) intramuscular ergometrine , and 20 IU oxytocin in 500 mL lactated Ringer's solution(infused at a rate of 125 mL/h)


Condition or disease Intervention/treatment Phase
Intraoperative Bleeding Drug: Tranexamic Acid Procedure: Cesarean section Not Applicable

Detailed Description:

A full medical history will be obtained from all participants. Obstetric ultrasonography and laboratory tests will be performed, including prothrombin time, prothrombin concentration, complete blood count, and liver and kidney function tests. Maternal body weight and vital signs (heart rate, blood pressure, and respiratory rate) will be checked 30 minutes before surgery. According to group assignment, either 1 g(10 mL) tranexamic acid (Kapron, Amoun, Egypt; stored in a dry container at 15 °C-30 °C) diluted in 20 mL of 5% glucose or 30 mL of 5% glucose will be slowly administered intravenously 15 minutes before skin incision over a 5-minute period.

Following delivery, patients in both groups will receive an intravenous bolus of 5 IU oxytocin (Syntocinon, Novartis, Basel, Switzerland), 1 mL(0.2 mg) intramuscular ergometrine (Methergin, Novartis, Basel, Switzerland), and 20 IU oxytocin in 500 mL lactated Ringer's solution(infused at a rate of 125 mL/h).

Fluid monitoring will be performed through rate of infusion and urine output. A complete blood count test will be performed 24 hours after delivery. On discharge, patients who received tranexamic acid will be given a brief orientation regarding symptoms and signs of a thromboembolic event and will be instructed to contact the investigators immediately if any occurred.

All patients will be examined for thromboembolic events at the 1- and 4-week follow-up visits

EBL will be calculated according to the formula:

EBL = EBV x Preoperative hematocrit−Postoperative hematocrit Preoperative hematocrit where EBV is estimated blood volume (mL; weight in kg × 85). For a two-tailed test at an α level of 0.05, the difference between the two groups regarding the primary outcome measure (EBL) had a power of 1.0 (100%) in a post hoc calculation.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Value of Tranxemic Acid to Reduce Intraoperative Blood Loss During Elective Cesarean Sections in High Risk Women: A Randomized Controlled Trial
Actual Study Start Date : January 31, 2019
Actual Primary Completion Date : November 15, 2019
Actual Study Completion Date : January 2, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Tranexamic acid group
1 g (10 mL) tranexamic acid (Kapron, Amoun, Egypt; stored in a dry container at 15 °C-30 °C) diluted in 20 mL of 5% glucose slowly administered intravenously 15 minutes before skin incision over a 5-minute period.
Drug: Tranexamic Acid
1 g (10 mL) tranexamic acid stored in a dry container at 15 °C-30 °C) diluted in 20 mL of 5% glucose slowly administered intravenously 15 minutes before skin incision over a 5-minute period.
Other Name: Kapron

Procedure: Cesarean section
Lower segement transverse cesarean section
Other Name: Lower segment elective cesarean section

Placebo Comparator: Control group
30 mL of 5% glucose slowly administered intravenously 15 minutes before skin incision over a 5-minute period.
Procedure: Cesarean section
Lower segement transverse cesarean section
Other Name: Lower segment elective cesarean section




Primary Outcome Measures :
  1. Estimated blood loss (EBL) during cesarean delivery [ Time Frame: during the operation ]

    EBL will be calculated according to the formula:

    EBL = EBV x Preoperative hematocrit−Postoperative hematocrit Preoperative hematocrit where EBV is estimated blood volume (mL; weight in kg × 85)




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • • Grand multipara

    • Multiple pregnancy
    • Polyhydraminos (AFI is more than 24 cm).
    • Placenta previa
    • Gestational diabetes mellitus
    • Preeclampsia
    • Anemia complicating pregnancy (Hemoglobin is less than 11 gm/dl)

Exclusion Criteria:

  • • Allergy to tranxemic acid.

    • H/o suggestive of bleeding disorders
    • previous history of deep vein thrombosis
    • Abnormally invasive placenta
    • Emergency cesarean sections
    • Intraoprative complications during cesarean sections as uterine artery injury and broad ligamentary hematoma.

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): NCT03820206


Locations
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Egypt
Kasr Alainy medical school
Cairo, Egypt, 12151
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Ahmed Maged, MD Professor
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Responsible Party: Ahmed M Maged, MD, Principal investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03820206    
Other Study ID Numbers: 50
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: January 6, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Blood Loss, Surgical
Hemorrhage
Pathologic Processes
Intraoperative Complications
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants