OBJECTIVE: To compare intramuscular oxytocin, Syntometrine and carbetocin for prevention of postpartum haemorrhage after vaginal birth.
DESIGN: Randomised double-blinded clinical trial SETTING: 6 hospitals in England POPULATION: 5929 normotensive women having a singleton vaginal birth.
METHODS: Randomisation when birth was imminent MAIN OUTCOME MEASURES: Primary: use of additional uterotonic agents. Secondary: weighed blood loss, transfusion, manual removal of placenta, side effects, quality of life.
RESULTS: Participants receiving additional uterotonics: 368 (19.5%) oxytocin, 298 (15.6%) Syntometrine and 364 (19.1%) carbetocin. When pairwise comparisons were made: women receiving carbetocin were significantly more likely to receive additional uterotonics than those receiving Syntometrine (OR 1.28, 95% CI 1.08-1.51, P=0.004); the difference between carbetocin and oxytocin was non-significant (p=0.78); Participants receiving Syntometrine were significantly less likely to receive additional uterotonics than those receiving oxytocin (OR 0.75, 95% CI 0.65-0.91, P=0.002). Non-inferiority between carbetocin and Syntometrine was not shown. Use of Syntometrine reduced non-drug PPH treatments compared with oxytocin (OR 0·64, 95%CI 0·42-0·97) but not carbetocin (p=0.64). Rates of PPH and blood transfusion were not different. Syntometrine was associated with an increase in maternal side effects and reduced ability to bond with her baby.
CONCLUSIONS: Non inferiority of carbetocin to Syntometrine was not shown. Carbetocin is not significantly different to oxytocin for use of additional uterotonics. Use of Syntometrine reduced use of additional uterotonics and need for non-drug PPH treatments compared with oxytocin. Increased maternal side effects are a disadvantage of Syntometrine.
|Number of pages||11|
|Journal||BJOG: An International Journal of Obstetrics and Gynaecology|
|Early online date||12 Jan 2021|
|Publication status||Published - Jun 2021|
Bibliographical noteFunding Information:
The costs for the trial medications and blinding were covered by Ferring Pharmaceuticals, with no further trial input. This funder had no role in study design, data collection, data analysis, data interpretation or writing of the report. The corresponding author had full access to all data in the study and had final responsibility for the decision to submit the publication. A small grant from North Bristol NHS Trust paid for some equipment and training costs. This study was included in the National Institute for Health Research Clinical Research Network Portfolio. Staffing costs were internally covered by Research and Innovation departments at participating sites. Thank you to members of the Maternity Service User Panel, and all members of staff involved in the conduct of this study.
© 2021 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd