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

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

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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)

Eligibility Criteria

• 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.

Contacts and Locations

Locations

Egypt

Kasr Alainy medical school

Cairo, Egypt, 12151

Sponsors and Collaborators

Cairo University

Investigators

• Principal Investigator: Ahmed Maged, MD; Professor

More Information

• Responsible Party: Ahmed M Maged, MD, Principal investigator, Cairo University
• ClinicalTrials.gov Identifier: NCT03820206
• Other Study ID Numbers: 50
• First Posted: January 29, 2019
• Last Update Posted: January 6, 2020
• Last Verified: January 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Blood Loss, Surgical; Hemorrhage; Pathologic Processes; Intraoperative Complications; Tranexamic Acid; Antifibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action; Hemostatics; Coagulants