Effect of Intravenous Tranexamic ACID on Blood Loss Reduction During and After Caesarean Section: A Randomised Controlled Study

Technical Summary: Effect of Intravenous Tranexamic Acid on Blood Loss Reduction During and After Caesarean Section

Problem Statement
Primary postpartum hemorrhage (PPH) remains a leading cause of maternal mortality and morbidity globally, with Caesarean section presenting significant risks for excessive blood loss. While oxytocic agents are standard interventions, there is a recognized need to explore additional modalities to further reduce hemorrhage. Tranexamic acid, an antifibrinolytic agent, has been approved for treating PPH, yet its specific efficacy in reducing blood loss during and immediately after elective Caesarean sections in the local context required further evaluation. This study aimed to determine the effectiveness of preoperative intravenous tranexamic acid in reducing blood loss and associated complications in women undergoing Caesarean section.

Methodology
The research was conducted as a double-blind, randomized controlled trial at the University of Abuja Teaching Hospital over a six-month period.

• Participants: 82 women with singleton pregnancies at 37–42 weeks gestation scheduled for elective Caesarean section were recruited. Inclusion criteria included women willing to participate without contraindications to tranexamic acid. Exclusion criteria encompassed coagulation disorders, sickle cell disease, chronic hypertension, renal/liver disease, diabetes, anticoagulant use, prior thromboembolism, preeclampsia, eclampsia, antepartum hemorrhage, and surgeries lasting longer than 90 minutes.
• Intervention: Participants were randomized into two groups (41 per arm) using computer-generated random numbers.
  • Group A (Intervention): Received 1g of intravenous tranexamic acid administered at 1ml/min over 10 minutes, starting 15 minutes before skin incision.
  • Group B (Control): Received 10ml of intravenous sterile water (placebo) under the same conditions.
• Procedure: All surgeries were lower segment Caesarean sections performed by consultants or senior registrars. Standard care included a 10IU IV oxytocin bolus after placental delivery. Additional uterotonics or surgical interventions were administered as clinically indicated.
• Data Collection & Analysis: Blood loss was estimated using the hemoglobin balance formula (incorporating Nadler's formula for Estimated Blood Volume). Hemoglobin and hematocrit levels were measured preoperatively and 48 hours postoperatively. Maternal vital signs were monitored at four specific intervals. Data were analyzed using SPSS version 24, with a p-value < 0.05 considered statistically significant.

Key Results
The study demonstrated statistically significant benefits in the tranexamic acid group compared to the placebo group:

• Blood Loss: The mean blood loss was significantly lower in the tranexamic group (725.1 ± 277.9 ml) compared to the placebo group (1183.02 ± 325.9 ml), representing a reduction of approximately 457.92 ml (p = 0.045).
• Hemoglobin and Hematocrit: The mean postoperative hemoglobin concentration was higher in the tranexamic group (10.50 ± 0.90 g/l) than in the placebo group (9.70 ± 0.86 g/l) (p < 0.0001). Consequently, the mean reduction in hemoglobin was significantly lower in the tranexamic group (0.49 ± 0.48 g/l) versus the placebo group (1.15 ± 0.16 g/l). Similar significant reductions were observed in hematocrit changes (1.06 ± 3.4% vs. 4.16 ± 3.98%).
• Uterotonic Requirement: The need for additional uterotonics was significantly lower in the tranexamic group (28.3%) compared to the placebo group (78.3%) (p < 0.0013).
• Non-Significant Findings: There were no statistically significant differences between the groups regarding the mean duration of surgery, the need for blood transfusion, or the incidence of blood loss exceeding 1,000 ml.
• Neonatal and Safety Outcomes: There was no significant difference in Apgar scores (1st and 5th minute) between the groups. No major side effects were reported in either group.

Significance and Claims
The authors conclude that the preoperative administration of intravenous tranexamic acid is an effective intervention for reducing blood loss and the subsequent need for additional uterotonics during Caesarean sections. The study claims that this intervention significantly mitigates the postoperative decrease in hemoglobin and hematocrit concentrations, thereby helping to prevent postpartum anemia.

The paper asserts that tranexamic acid possesses a favorable safety profile, evidenced by the absence of major side effects and no adverse impact on fetal outcomes (Apgar scores). While the study did not find a statistically significant reduction in the rate of massive hemorrhage (>1000ml) or blood transfusion requirements, the authors position tranexamic acid as a viable adjunct to standard care for reducing PPH and its complications. The study suggests that a multicenter randomized controlled trial is necessary to generalize these findings further.