Intravenous carbetocin versus intravenous oxytocin for preventing atonic postpartum hemorrhage after normal vaginal delivery in high-risk singleton pregnancies: a triple-blind randomized controlled trial
To compare the effectiveness of intravenous carbetocin to that of intravenous oxytocin for prevention of atonic postpartum hemorrhage (PPH) after vaginal delivery in high-risk singleton pregnancies.
This triple-blind randomized controlled trial included singleton pregnant women who delivered at Siriraj Hospital between August 2016 and January 2017 and who were 20 years or older, had a gestational age of at least 34 weeks, had a vaginal delivery, and had at least one risk factor for atonic postpartum hemorrhage. Immediately after vaginal delivery, participants were randomly assigned to receive either 5 U of oxytocin or 100 mcg of carbetocin intravenously. Postpartum blood loss was measured objectively in mL using a postpartum drape with a calibrated bag.
A total of 174 and 176 participants constituted the oxytocin and carbetocin groups, respectively. The baseline characteristics were comparable between the groups. The carbetocin group had less postpartum blood loss (146.7 ± 90.4 vs. 195.1 ± 146.2 mL; p < 0.01), a lower incidence of atonic PPH (0 vs. 6.3%; p < 0.01), less usage of additional uterotonic drugs (9.1 vs. 27.6%; p < 0.01), and a lower incidence of postpartum anemia (Hb ≤ 10 g/dL) (9.1 vs. 18.4%; p < 0.05) than the oxytocin group. No significant differences regarding side effects were evident between the groups.
Intravenous carbetocin is more effective than intravenous oxytocin for the prevention of atonic PPH among singleton pregnancies with at least one risk factor for PPH.
Clinical trial registration
KeywordsCarbetocin High-risk pregnancy Obstetric delivery Oxytocin Postpartum hemorrhage
The authors gratefully acknowledge Mr. Suthipol Udompunthurak for assistance with the statistical analysis. We are also grateful to a grant obtained from the Siriraj Research Development Fund, which is managed by the Routine to Research Project (R2R) and to 100 doses of carbetocin used in this study which were supported unconditionally by Ferring Pharmaceutical Ltd., Thailand.
TL: protocol/project development, data analysis and interpretation, manuscript writing/editing, final form of manuscript. PA: data collection and management, manuscript writing, funding management. DB: protocol/project development, data analysis and interpretation. JL: data collection and management. RS: data collection and management. RJ: data collection and management, funding management.
This study was funded by the Siriraj Research Development Fund, which is managed by the Routine to Research Project (R2R; Grant number 16OG00021/044/16). The one hundred doses of carbetocin used in this study were provided unconditionally by Ferring Pharmaceutical Ltd., Thailand. The funders had no role in the processes of the study design, data collection, decision to publish, or preparation of the manuscript.
Compliance with ethical standards
Conflict of interest
Assistant professor Tripop Lertbunnaphong has received a speaker honorarium from Ferring Pharmaceutical Ltd., Thailand. Paweena Amornpetchakul, Dittakarn Boriboonhiransarn, Jarunee Leetheeragul, Ratree Sirisomboon and Ratchada Jiraprasertwong declare that they have no conflict of interest.
Research involving human participants and/or animals
Ethics approval: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.
Informed consent was obtained from all individual participants included in the study.
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