Abstract
Objectives
To evaluate the uterotonic effect of carbetocin compared with oxytocin in emergency cesarean delivery in Iraq.
Methods
A double-blinded randomized noninferiority single center trial. Three-hundred patients were systematically randomized to intravenous bolus injection of 10 IU oxytocin or 100 mcg carbetocin after delivery in a ratio of 2:1. The primary outcome was additional uterotonic use when inadequate uterine tone occur in the first 24 h after delivery. Secondary outcomes include the need for blood transfusion, blood pressure and pulse rate changes within an hour of drugs administration. Noninferiority margins for the relative risks outcomes was 4%.
Results
Addition uterotonics use was significantly lower in carbetocin group with a risk ratio of 0.36. Carbetocin was superior to oxytocin in reducing the need for additional uterotonic drugs by 12% and non-inferior to oxytocin for blood transfusion 3.5%. Noninferiority was not shown for the outcome of sever blood loss. Miner changes in blood pressure and pulse rate were observed in carbetocin group compared to oxytocin but clinically were not significant.
Conclusions
Heat stable carbetocin is effective in reducing additional uterotonics use compared to oxytocin without clinically significant change in blood pressure or pulse rate, therefore, can be a potential alternative in Iraq.
Acknowledgments
The authors would like to thank Al Resafa Health Directorate for supplying the used drug for this research work. They are also thankful to Al Elwiya Maternity Teaching Hospital medical staff, namely the manager, Dr. Ulfat Alnakkash for their support and Al-Kindy Medical School at the University of Baghdad for supporting registration of this trial. Special gratitude to Dr. Ahmed S Alnuaimi for his valuable expert scientific analysis for the data.
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Research funding: None declared.
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Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
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Competing interests: Authors state no conflict of interest.
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Informed consent: Informed consent was obtained from all individuals included in this study.
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Ethical approval: The protocol was approved by the Scientific Affairs Unit and Medical Ethics Committee at Al Kindy College of Medicine and the hospital administrative boards’ official order (No 167 in 25/12/2017).
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