Comparison of the Efficacy of Carbetocin vs Oxytocin in Preventing PPH in Women Undergoing Vaginal Delivery: A Prospective Randomized Controlled Trial from Tamil Nadu, India

Abstract

Background: A heat-stable analog of oxytocin, known as carbetocin, which has an extended half-life, can serve as a viable alternative uterotonic agent for preventing postpartum hemorrhage (PPH). Several clinical trials and systematic reviews have demonstrated the effectiveness of heat-stable carbetocin (HSC), especially in low-income countries. However, to put this into practice, program directors need comprehensive information about its effectiveness and the economic feasibility related to its storage, transportation, and use. Objective: The objective of this study is to assess the efficacy of HSC in comparison to oxytocin for the prevention of PPH in women who are having a vaginal delivery. Materials and methods: This was a prospective randomized controlled trial with a single-blind design and a 1:1 allocation ratio. The study lasted 1 year, from April 2022 to May 2023. A total of 194 women with singleton pregnancies undergoing vaginal delivery were evenly divided into two groups. Demographic details regarding the patients, such as age, parity, and gestational age, were documented. A thorough history and obstetric evaluation of the participants were conducted, and hemoglobin levels were assessed at the time of admission and prior to delivery. Immediately after the baby was delivered, 97 participants in group A were administered 100 mg of HSC intramuscularly, while 97 participants in Group B received 10 IU of oxytocin along with intensive management of the third stage of labor in accordance with WHO guidelines. The volume of blood loss, changes in hemoglobin levels, and the incidence of adverse effects were examined postdelivery to evaluate the effectiveness of both medications. Results: A statistically significant difference was noted in hemoglobin levels 24 h postdelivery (10.83 ± 1.26 vs 11.55 ± 1.20, p-value <0.05), along with the volume of blood loss in both groups, higher in those who received oxytocin compared to carbetocin. Specifically, 34 out of 97 participants (35.1%) in the oxytocin group and 64 out of 97 participants (66.0%) in the carbetocin group had blood loss of less than 250 mL. Moreover, 60 participants in the oxytocin group (61.8%) and 31 in the carbetocin group (31.9%) had blood loss between 250 and 500 mL. However, no significant differences were found between the two groups regarding major PPH (>1,000 mL), the need for additional uterotonic agents, or adverse effects. Conclusion: This study finds that carbetocin is more effective than oxytocin in reducing postpartum blood loss in women having singletonterm vaginal births. Carbetocin is stable at high temperatures and can be given as a single dose. Therefore, it is suitable for standard prophylaxis of PPH in developing nations like India.