COPE Study - Update 25th September 2019
The COPE study is a national NIHR funded study to compare intramuscular carboprost 250 micrograms with intravenous oxytocin 10 international units for the initial treatment for women with clinically diagnosed postpartum haemorrhage after giving birth in UK hospitals. The study is designed to be a double-blind, double-dummy, randomised controlled trial.
Women recruited to the study would be randomised to receive either carboprost 250 micrograms by deep intramuscular injection and 1ml placebo by slow intravenous injection (the intervention group) or oxytocin 10 international units (iu) by slow intravenous injection and 1ml placebo by deep intramuscular injection (the control group). The protocol allows for the intravenous dose to be diluted in 10 mls of saline before injection.
This is an important study but members have contacted the OAA to express concern about being requested to potentially administer oxytocin 10 iu dose as an intravenous bolus as this is contrary to standard anaesthetic practice in the UK (Bolton, T J, Randall, K, and Yentis, S M. Anaesthesia. 58.3 (2003): 277-79) following the recommendation in the 1997-99 Confidential Enquiry into Maternal Deaths (Thomas T and Cooper GM, Why Mothers Die 1997-1999, Chapter 9, pp 134-149). In the British National Formulary (BNF) the recommended dose of oxytocin during caesarean section is 5 iu by slow intravenous injection immediately after delivery, but the BNF recommends a dose of oxytocin 5 iu by slow intravenous injection for treatment of postpartum haemorrhage and this dose can be repeated.
The OAA has contacted the COPE study Chief Investigator, Professor Andrew Weeks, to convey the concerns of our members.
After discussion with the OAA, the COPE investigators plan to change the protocol so that anaesthetists can give 5iu syntocinon. The drug will come in the usual 1ml ampoule containing 10iu, and study teams will then be advised to draw up the study drug in 10mls of saline and inject 5ml over at least 2 minutes. The dose and speed of injection will be recorded so that the effect of dose on outcomes and side effects can be analysed.