Effect of heat stable carbetocin vs oxytocin for preventing postpartum haemorrhage on post delivery hemoglobin-a randomized controlled trial

To compare the effect of heat-stable carbetocin 100 μg IM versus oxytocin 10 IU IM on post-delivery hemoglobin level. Hospital based study in Southern India. Women delivering vaginally who were enrolled in the WHO CHAMPION trial in a single facility in India. WHO CHAMPION Trial was a randomized, dou...

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Published in:The journal of maternal-fetal & neonatal medicine 2022-01, Vol.35 (25), p.8744-8751
Main Authors: Vernekar, Sunil S., Goudar, Swati S., Metgud, Mrityunjay, Pujar, Yeshita V., Somannavar, Manjunath S., Piaggio, Gilda, Carvalho, José Ferreira D. E., Revankar, Amit, Althabe, Fernando, Widmer, Mariana, Gulmezoglu, Ahmet Metin, Goudar, Shivaprasad S.
Format: Article
Language:English
Subjects:
heat-stable carbetocin
oxytocin
post-delivery hemoglobin
Post-partum hemorrhage
uterotonics
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Summary:To compare the effect of heat-stable carbetocin 100 μg IM versus oxytocin 10 IU IM on post-delivery hemoglobin level. Hospital based study in Southern India. Women delivering vaginally who were enrolled in the WHO CHAMPION trial in a single facility in India. WHO CHAMPION Trial was a randomized, double-blind, noninferiority trial comparing intramuscular injections of heat-stable carbetocin with oxytocin administered immediately after vaginal birth in women across 23 sites in 10 countries. This 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 hemorrhage, on post-delivery 48-72 h hemoglobin level, adjusted for pre-delivery hemoglobin level. 1,799 women from one hospital in India participated in this study. Pre-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 (10.09 g/dL) compared to oxytocin (10.21) (p value of 0.0432). 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) (p value of .0786). 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 1.02-1.63). From the regression coefficients it can be derived that post-delivery hemoglobin, adjusted for pre-delivery hemoglobin, decreases on average 0.12 g/dL for each dL of blood lost, for the two treatments combined. The 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.
ISSN:1476-7058
1476-4954
DOI:10.1080/14767058.2021.2001799