Clinical trial NCT03820206: The Value of Tranxemic Acid to Reduce Intraoperative Blood Loss During Elective Cesarean Sections in High Risk Women
Official title: The Value of Tranxemic Acid to Reduce Intraoperative Blood Loss During Elective Cesarean Sections in High Risk Women: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intraoperative Bleeding
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-01-29
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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)

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.

Eligibility 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.

Primary outcomes:
measure: Estimated blood loss (EBL) during cesarean delivery
timeFrame: during the operation
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy medical school
Study officials:
affiliation: Professor
name: Ahmed Maged, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shalaby MA, Maged AM, Al-Asmar A, El Mahy M, Al-Mohamady M, Rund NMA. Safety and efficacy of preoperative tranexamic acid in reducing intraoperative and postoperative blood loss in high-risk women undergoing cesarean delivery: a randomized controlled trial. BMC Pregnancy Childbirth. 2022 Mar 14;22(1):201. doi: 10.1186/s12884-022-04530-4.