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New drug trial offers hope to women who miscarry

Doctors at Saint Mary's Hospital are inviting women who have had three or more unexplained miscarriages to take part in a trial of a new drug treatment which may help to reduce the risk of miscarriage.

The PROMISE (Progesterone in Recurrent Miscarriage) trial is using progesterone treatment in women who have had three or more miscarriages (which do not have to be one after another, some participants have had one miscarriage, a baby and then two or more miscarriages), and comparing it with a placebo (dummy drug).

Manchester is one of a network of centres in England, Scotland and the Netherlands taking part in the study, which is funded by the National Institute for Health Research (NIHR).

The lead investigator at Saint Mary's is Dr Edmond Edi-Osagie, supported by research nurse Lucy Dwyer, and recruitment for the trial has now begun.

"In many cases, there is no clear explanation about why a woman loses her baby, and it can be very upsetting and worrying for couples if they experience repeated miscarriages," said Dr Edi-Osagie.  "The purpose of this study is to find out whether treating these women with progesterone, a natural pregnancy hormone, from the time of a positive pregnancy test until 12 weeks of pregnancy decreases their chance of miscarrying."

Women taking part in the Trial administer pessaries twice a day at home, from the time they have a positive pregnancy test until they have used up the entire pack, which should take them to approximately 12 weeks of their pregnancy. .  The research team will follow up each participant regularly during the trial period and then keep in touch as the pregnancy progresses and after their babies are born.

Dr Edi-Osagie added:  "We do not know if the study will help the women who participate personally, but the information we will get may improve the pregnancy outcome for women in the future."

The research is sponsored by Imperial College, London (Chief Investigator - Dr Raj Rai) and managed by the University of Birmingham (Trial Manager - Prof Arri Coomarasamy) - more information is available at http://www.medscinet.net/promise.  The Manchester site is also supported by the NIHR Manchester Biomedical Research Centre.

If you would like more information about the trial please contact Lucy Dwyer at Saint Mary's Hospital at lucy.dwyer@cmft.nhs.uk or on 07779 160534 or bleep 2335 via switchboard 0161 276 1234. You do not need to be referred to the PROMISE trial by your GP but you may require additional tests to determine whether you are eligible to participate or not.