Journal of South Asian Federation of Obstetrics and Gynaecology

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VOLUME 16 , ISSUE S2 ( August, 2024 ) > List of Articles

RESEARCH ARTICLE

Randomized Parallel Trial of Intramyometrial Injection of Heat-stable Carbetocin vs Intramyometrial Injection of Oxytocin for the Prevention of Postpartum Hemorrhage during Cesarean Delivery

Rajasri G Yaliwal, Preeti S Malapure

Keywords : Carbetocin, Cesarean delivery, Intramyometrial, Novel, Postpartum hemorrhage

Citation Information :

DOI: 10.5005/jp-journals-10006-2489

License: CC BY-NC 4.0

Published Online: 02-09-2024

Copyright Statement:  Copyright © 2024; The Author(s).


Abstract

Aim and background: Among various causes of maternal mortality, the leading direct cause of maternal mortality is bleeding. More than half of postpartum hemorrhages are brought on by insufficient uterine contraction following placental delivery [Atonic postpartum hemorrhage (PPH)]. Several uterotonics are available, including oxytocin and carbetocin. This study is the first to use carbetocin via the intramyometrial route for the prophylaxis of postpartum hemorrhage. We aim to contrast the safety and effectiveness of intramyometrial injection of carbetocin vs intramyometrial injection of oxytocin to prevent postpartum bleeding during cesarean delivery. Materials and methods: In the Obstetrics and Gynecology Department of Shri BM Patil MCH & RC, BLDE (DU), Vijayapura, Karnataka, India, this randomized parallel trial was conducted from August 2021 to July 2022. Women in group I received 100 μg carbetocin intramyometrially immediately after birth of baby but before separation of placenta, injected into the anterior uterine wall. Women in group II received 10 units of oxytocin intramyometrially immediately after birth of baby but before separation of placenta, injected into the anterior uterine wall. The outcomes measured were total blood loss and uterine tone at 1, 3, 5, and 10 minutes after injection, hemodynamic parameters, need for blood and blood products and additional uterotonics and adverse events. Results: The difference in the preoperative and postoperative hemoglobin was nearly equal in both the groups 0.943 gm/dL in group I and 0.912 gm/dL in group II (p-value < 0.001). The tone of the uterus was well contracted from 5 minutes in both the groups. Additional uterotonics were used for 2 cases in group I and 4 cases in group II. These findings are consistent with non-inferiority as seen in the champion trial. Two patients in group I and one in group II underwent blood transfusions. Group I showed no adverse consequences, whereas group II only showed one case of a statistically insignificant negative event. Conclusion: Intramyometrial injection of carbetocin is non-inferior to intramyometrial injection of oxytocin in terms of efficacy and safety. Clinical significance: This study explores an alternative route for the administration of carbetocin for postpartum hemorrhage prophylaxis. This study opens up the prospective of better local action, possible quick action in emergencies and fewer systemic side effects compared to the traditional route.


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