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COPE

COPE

COPE

COPE
Funding National Institute for Health Research (NIHR) Health Technology Assessment (HTA)
Portfolio Paediatric, foetal and maternal health
Interventions Medicine
Randomised Yes
Status Funding awarded/in set-up
Start Date 01-Jan-0001

Background and study aims
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, the PPH rate is increasing; laboratory studies suggest that repeated use of oxytocin leads to 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 treatment due to side effects of diarrhoea and vomiting and its cost. The aim of this study is to compare the two drugs, carboprost and oxytocin, currently used to treat PPH, to find out whether it is better to use carboprost or oxytocin as the first drug for treatment for PPH.
Who can participate?
Women aged 16 and over with PPH
What does the study involve?
Participants are randomly allocated to one of two groups. Two injections are administered. One group receives carboprost and placebo (dummy drug) and the other group receives oxytocin and placebo (dummy drug). There are no extra clinic visits required. Data is collected from medical records. Each participant is followed up 24 hours and 4 weeks later to complete a questionnaire and collect information regarding their healthcare resource use and quality of life. Paper follow-up documents are posted to the homes of participants for their completion
What are the possible benefits and risks of participating?
The results will help doctors know which treatment is better for PPH treatment. The benefits of participation are that women will receive optimal care, with researchers, clinicians and regulators observing and checking their care carefully so as to ensure that no mistakes are made. This is why clinical outcomes of participants in any study tend to be much better than those of non-participants, irrespective of what treatment they receive. The risks are that of the treatments, both of which are already commonly used as part of PPH management. The common side effects of both treatments are as follows: oxytocin: headache, nausea, vomiting, low blood pressure, water retention; carboprost: diarrhoea, vomiting, high temperature, increased blood pressure

Publications

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