COPE
Research type
Research Study
Full title
The Carboprost or Oxytocin Postpartum haemorrhage Effectiveness Study. Carboprost vs Oxytocin as the First Line Treatment of Primary Postpartum Haemorrhage; A phase IV, double-blind, double-dummy, randomised controlled trial.
IRAS ID
235254
Contact name
Andrew Weeks
Contact email
Eudract number
2018-001829-11
Duration of Study in the UK
3 years, 5 months, 1 days
Research summary
Excessive bleeding after childbirth (postpartum haemorrhage, PPH) is a common and potentially serious problem affecting 1 in 20 women. Each year it causes 75,000 deaths worldwide. It also causes weakness from anaemia, delayed recovery, psychological trauma, and poor breastfeeding and bonding with their baby.
Oxytocin is recommended as first line treatment for PPH, as it is low cost, effective and has very few side effects. However, PPH rate is increasing; laboratory studies suggest that repeated use of oxytocin leads to its reduced effectiveness. Carboprost is an alternative treatment and there is evidence that it is more effective than oxytocin, but it is usually reserved for second/third line therapy due to side effects of diarrhoea, vomiting and cost.
COPE is a research study to compare the two drugs, carboprost and oxytocin, currently used to treat PPH. About 4000 women will take part across approximately 40 UK NHS hospitals, and we want to know if it is better to use carboprost or oxytocin as the first drug for treatment of PPH. Any woman ≥ 16 years of age who experiences a PPH can participate in the study.
Two injections will be administered. One group will receive carboprost and placebo (dummy drug) and the other group will receive oxytocin and placebo (dummy drug). The results will help doctors know which treatment is better for PPH treatment. Women will be allocated by a computer ‘at random’ into one of the groups so neither the woman nor their doctor chooses the treatment. Women are equally as likely to be in each of the groups. COPE is a ‘blinded study’ so neither the woman or their doctor will know what treatment is given.
The study will run from September 2018 to September 2021 with recruitment starting approximately November 2018. Participant duration will be approximately 4 weeks.REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
18/WM/0227
Date of REC Opinion
4 Oct 2018
REC opinion
Further Information Favourable Opinion