Comparison of the Effectiveness, Safety, and Hemodynamic Profile of Prophylactic Administration of Carbetocin vs. Oxytocin for the Prevention of Postpartum Hemorrhage in High-Risk Cesarean Sections: A Randomized, Double-Blind Clinical Trial

卡贝缩宫素与催产素预防高危剖宫产产后出血的有效性、安全性和血液动力学特征比较:一项随机、双盲临床试验

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Abstract

Background Postpartum hemorrhage (PPH) is a major cause of maternal morbidity and mortality, particularly in low-resource settings. Cesarean delivery increases the risk of PPH, with uterine atony being the most common cause. Oxytocin is widely used for prevention, but has limitations due to its short half-life and storage concerns. Carbetocin, a long-acting oxytocin analogue, may offer a more stable alternative. Objective This study's objective was to compare the effectiveness, safety, and hemodynamic profile of prophylactic carbetocin vs. oxytocin for PPH prevention in high-risk cesarean deliveries. Methods The randomized, double-blind, controlled trial enrolled 70 high-risk term pregnant women undergoing elective cesarean section under spinal anesthesia. Participants were randomized to receive either carbetocin 100 µg IV bolus (group E) or oxytocin 10 IU infusion (group C - control). Uterine tone, intraoperative blood loss, additional uterotonic requirement, hemodynamic parameters, and adverse effects were assessed. An independent t-test was used for comparing quantitative variables, and the chi-square test was used for qualitative variables between the groups. Results The carbetocin group had significantly adequate uterine tone (Likert scores 4 vs. 3), lower need for additional uterotonics (2.86% vs. 28.57%, p = 0.0086), and reduced intraoperative blood loss (<500 mL in 82.86% vs. 42.86%, p = 0.001). The adequacy of uterine tone was highly significant (p < 0.0001) after three minutes of uterotonic administration in the carbetocin group. The carbetocin group had significantly higher mean arterial pressure (MAP) (e.g., 85.31% vs. 80% at five minutes; 89.89% vs. 82.14% at uterine repair; 91.09% vs. 86.09% at two hours) and lower heart rate (HR) (92.31% vs. 104.69% at five minutes; 90.8% vs. 101.14% at uterine repair) compared to the oxytocin group. Conclusion Carbetocin is a safer alternative to oxytocin for prophylactic administration to prevent PPH in high-risk cesarean deliveries with a favorable hemodynamic and safety profile.

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