Effect of Heat stable Carbetocin vs Oxytocin for Preventing Postpartum Haemorrhage on Post Delivery Hemoglobin- A Randomized Controlled Trial

Abstract BackgroundPost-partum haemorrhage is one of the major causes of maternal mortality in low- and middle-income countries. Oxytocin is the first choice uterotonic for the PPH prevention but it requires cold storage. Heat stable carbetocin appears to be a promising agent for the prevention of PPH. The present study was an ancillary to the WHO CHAMPION Trial conducted to compare the effect of heat-stable carbetocin 100 µg IM versus oxytocin 10 IU IM on post-delivery hemoglobin level in one of the participating facilities in India.MethodsThis was a nested randomized controlled trial designed to compare the effect of heat-stable carbetocin 100 µg IM versus oxytocin 10 IU IM, administered within one minute of vaginal delivery of the baby for prevention of postpartum haemorrhage, on post-delivery 48–72 hours hemoglobin level, adjusted for pre-delivery hemoglobin level. 1,799 women from one hospital in India participated in this study.ResultsPre-delivery hemoglobin and postpartum blood loss were not significantly different between carbetocin and oxytocin. Post-delivery hemoglobin, unadjusted or adjusted for pre-delivery hemoglobin, was slightly lower for carbetocin compared to oxytocin. The drop in hemoglobin was slightly higher for carbetocin, although the difference was very small (1.2 g/dL for carbetocin, 1.1 g/dL for oxytocin). The proportion of participants with a drop in hemoglobin of 2 g/dL or more, adjusted for pre-delivery hemoglobin, was higher for carbetocin (RR = 1.29, 95% CI 1.02 to 1.63). From the regression coefficients it can be derived that post-delivery hemoglobin, adjusted for pre-delivery hemoglobin, decreases on average 0.12g/dL for each dL of blood lost, for the two treatments combined.ConclusionsThe present ancillary study showed that intramuscular administration of 100 µg of heat stable carbetocin can result in a slightly lower post-delivery hemoglobin, slightly higher drop and higher percentage of women having a drop of 2 g/dL or larger, compared to 10 IU of oxytocin, but these differences are not clinically relevant.Study registrationThe trial was registered with Clinical Trial Registry of India CTRI/2016/06/006996.