PRISM: PRogesterone In Spontaneous Miscarriage
Research type
Research Study
Full title
Effectiveness of progesterone to prevent miscarriage in women with early pregnancy bleeding: A randomised placebo-controlled trial (PRISM Trial: PRogesterone In Spontaneous Miscarriage Trial)
IRAS ID
158326
Contact name
Aravinthan Coomarasamy
Contact email
Sponsor organisation
University of Birmingham
Eudract number
2014-002348-42
Clinicaltrials.gov Identifier
Sponsor Pink Form, eCEM 0213; Sponsor Contracts Request, 14-0546; Sponsor SAF Number, ERN_14-0619
Duration of Study in the UK
2 years, 11 months, 30 days
Research summary
One in five pregnancies miscarry, and the loss of an unborn baby has the potential to cause both physical harm and psychological distress. A recently launched NICE guideline (CG154, Dec 2012) has urged that a large and robust randomised controlled clinical trial should be conducted to clarify the evidence that progesterone treatment for women with bleeding in early pregnancy could reduce the risk of miscarriage.
We will ask women who have bleeding in early pregnancy (up to 12 weeks) whether they would be willing to take part in this study. If they are eligible and give written consent, they will receive either progesterone or placebo (inactive) capsules, to insert vaginally twice a day up to 16 weeks of pregnancy. Neither the women nor the research doctors or nurses will know what treatment (progesterone or placebo) they have been given. The principal outcome of the study will be live birth beyond 34 weeks of pregnancy. A number of other key outcomes, including gestation at birth, miscarriage rates and the condition of the baby at 28 days of life, will also be collected and analysed. We will additionally gather resource-use outcomes to perform a health economic evaluation.
We aim to recruit 4150 women over one year into this study. This number of participants will enable us to detect a Minimally Important Difference (MID) of 5% in live birth beyond 34 weeks. Participants will be randomised to receive either active or placebo treatment in a 1:1 ratio.
The study is supported by the Association of Early Pregnancy Units (AEPU), the Miscarriage Association and the Early Pregnancy Clinical Studies Group.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
14/SC/1345
Date of REC Opinion
26 Nov 2014
REC opinion
Further Information Favourable Opinion