The Prophylactic Role of Tranexamic Acid in Reducing Blood Loss During Cesarean Delivery: A Prospective Randomized Controlled Trial.
TXA may reduce intraoperative blood loss during cesarean delivery, but the clinical relevance of the findings is uncertain due to small effect sizes and study limitations.
Where it sits
this study against the rest of the carbetocin corpusSummary and findings
This study evaluated the effect of intravenous tranexamic acid (TXA) on intraoperative blood loss during cesarean delivery in 300 participants. The mean estimated blood loss (EBL) was lower in the TXA group at 460.33 mL compared to 511.93 mL in the placebo group (p < 0.05). No significant differences were noted in hemoglobin levels or the need for additional uterotonics.
Abstract
Background Postpartum hemorrhage (PPH) is a major risk associated with cesarean delivery. This randomized controlled trial (RCT) aimed to evaluate the prophylactic role of intravenous tranexamic acid (TXA) in reducing total intraoperative blood loss in women undergoing lower-segment cesarean section (LSCS). Materials and methods The study was conducted at the Autonomous State Medical College, Fatehpur, from September 1, 2024, to March 31, 2025. The primary aim of the trial was to investigate the effect of TXA on perioperative and postoperative blood loss during cesarean section in a low-resource setting. A simple randomization technique was used to allocate 300 participants to either group in a 1:1 ratio. Results The median estimated blood loss (EBL) was identical in both groups at 450 mL (IQR, 250-1000 mL), as measured by the gravimetric method. The mean EBL was lower in the TXA group (460.33 mL) than in the placebo group (511.93 mL) (p < 0.05). The mean changes in hemoglobin level and packed cell volume (PCV) were similar between the two groups. There was no statistically significant difference between the groups in the need for additional uterotonics (misoprostol, carboprost, or carbetocin). Blood transfusions were required in 4.7% (7 cases) of the TXA group and 9.3% (14 cases) of the placebo group. Gastrointestinal side effects were reported in 42.0% of the TXA group and 37.3% of the placebo group. No thromboembolic events were reported in either group. The mean birth weight and mean APGAR scores at one minute were comparable between the two groups. Conclusion This study supports the prophylactic use of TXA during cesarean delivery to reduce intraoperative blood loss. The significant reduction in mean EBL, combined with the absence of major adverse effects, underscores the role of TXA as a safe and effective adjunct to standard uterotonic therapy.
Background
Postpartum hemorrhage (PPH) is a significant risk associated with cesarean deliveries, necessitating effective interventions to reduce blood loss. Tranexamic acid (TXA) has been proposed as a potential adjunct to standard uterotonic therapy. Previous studies have shown mixed results regarding the efficacy of TXA in surgical settings, making this randomized controlled trial (RCT) relevant for assessing its role specifically in cesarean deliveries.
Methods
This RCT was conducted at the Autonomous State Medical College, Fatehpur, from September 1, 2024, to March 31, 2025. A total of 300 participants were randomly allocated to receive either intravenous TXA or a placebo in a 1:1 ratio. The primary outcome measured was the total intraoperative blood loss during lower-segment cesarean section (LSCS).
Results
The primary endpoint revealed that the mean estimated blood loss (EBL) was significantly lower in the TXA group at 460.33 mL compared to 511.93 mL in the placebo group (p < 0.05). The median EBL was reported as identical at 450 mL (IQR, 250-1000 mL) for both groups. There were no significant differences in hemoglobin levels or the need for additional uterotonics between the groups.
Interpretation
While the study demonstrates a statistically significant reduction in mean EBL with TXA, the clinical significance of this finding may be limited given the small effect size and the lack of a substantial difference in hemoglobin levels or transfusion needs. The absence of major adverse effects is noted, but the study's limitations, including its setting and sample size, may affect the applicability of the results to broader populations.
Key findings
- Mean EBL in TXA group was 460.33 mL vs 511.93 mL in placebo group, p < 0.05.
- Median EBL was identical at 450 mL (IQR, 250-1000 mL) in both groups.
- Blood transfusions required in 4.7% (7 cases) of TXA group vs 9.3% (14 cases) of placebo group.
- Gastrointestinal side effects reported in 42.0% of TXA group vs 37.3% of placebo group.
- No thromboembolic events reported in either group.
Limitations
- Sample size of 300 may limit generalizability.
- Study conducted in a low-resource setting.
- No follow-up duration reported.
- No significant differences in hemoglobin levels or transfusion needs.
- Gastrointestinal side effects reported in both groups.