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

Abstract

Objective

To compare the effect of heat-stable carbetocin 100 μg IM versus oxytocin 10 IU IM on post-delivery hemoglobin level.

Setting

Hospital based study in Southern India.

Population

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.

Methods

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.

Results

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.

Conclusion

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.

Keywords:

• Post-partum hemorrhage
• heat-stable carbetocin
• post-delivery hemoglobin
• uterotonics
• oxytocin

Acknowledgement

We gratefully acknowledge the contributions of all the study investigators and data collectors towards the implementation of this study.

Authors’ contributions

SSV conceived of the manuscript and wrote the first draft with input from MSS, SSG, GP, JFC, AMG and MW. SSV, SSG, MM, YVP, AR, MSS and SSG oversaw study implementation, data collection and quality monitoring. GP and JFC performed the statistical analyses. All authors reviewed and approved the final manuscript.

Disclosure statement

No potential conflict of interest was reported by the author(s).

The main trial was supported by funding from MSD, through its MSD for Mothers program and is the sole responsibility of the authors. MSD for Mothers is an initiative of Merck & Co., Inc., Kenilworth, NJ, U.S.A. The study was funded by KLE Academy of Higher Education & Research.

Clinical trial registration

The trial was registered with Clinical Trial Registry of India CTRI/2016/06/006996.

Availability of data and materials

The datasets generated during and/or analyzed during the current study are available in the World Health Organization repository. The link to datasets can be requested to Mariana Widmer at [email protected]

Additional information

Funding

The author(s) reported there is no funding associated with the work featured in this article.