Prescribing progesterone to women with early pregnancy bleeding and a history of miscarriage could prevent more than 8,000 miscarriages a year, according to two studies published today.
Research published by the University of Birmingham and Tommy’s National Centre for Miscarriage Research says there are scientific and economic advantages to prescribing a course of self-administered progesterone pessaries to women from when they first present with early pregnancy bleeding up until 16 weeks of pregnancy.
The scientists behind the studies are now calling for progesterone to be offered as standard in the NHS for those at-risk women.
The first study, published in the American Journal of Obstetrics and Gynecology, examines the findings of two major clinical trials – PROMISE and PRISM – led by the University of Birmingham and Tommy’s National Centre for Miscarriage Research and funded by the National Institute for Health Research (NIHR).
PROMISE , which studied 836 women with unexplained recurrent miscarriages at 45 hospitals in the UK and the Netherlands, found a 3% higher live birth rate with progesterone, but with substantial statistical uncertainty.
PRISM, which studied 4,153 women with early pregnancy bleeding at 48 hospitals in the UK, found there was a 5% increase in the number of babies born to those who were given progesterone who had previously had one or more miscarriages compared to those given a placebo.
The benefit was even greater for the women who had previous recurrent miscarriages, with a 15% increase in the live birth rate in the progesterone group compared to the placebo group.
The second study, which is also published today in BJOG: an international Journal of Obstetrics & Gynaecology, evaluates the economics of the PRISM trial and concludes that progesterone is cost-effective, costing an average £204 per pregnancy.
Dr Adam Devall, senior clinical trial fellow at the University of Birmingham and Manager of Tommy’s National Centre for Miscarriage Research, said: “Between 20% and 25% of pregnancies end in a miscarriage, which has a major clinical and psychological impact on women and their families.
“We believe that the dual risk factors of early pregnancy bleeding and a history of one or more previous miscarriages identify high risk women in whom progesterone is of benefit. The question is, how should this affect clinical practice?”
Professor Arri Coomarasamy, professor of gynaecology at the University of Birmingham and Director of Tommy’s National Centre for Miscarriage Research, added: “In the United Kingdom, we estimate that implementing this treatment strategy would result in an additional 8,450 live births per year. We now urge policymakers and guideline developers to consider the evidence carefully to make a balanced recommendation.”
Jane Brewin, Tommy’s chief executive, called on NICE to amend the guidelines and for NHSE to encourage take-up of this treatment across the country.
Coomarasamy A et al. Micronized vaginal progesterone to prevent miscarriage: a critical evaluation of randomized evidence. American Journal of Obstetrics and Gynecology. 31 January 2020; doi: 10.1016/j.ajog.2019.12.006.
Okeke Ogwulu et al. The cost-effectiveness of progesterone in preventing miscarriages in women with early pregnancy bleeding: an economic evaluation based on the PRISM Trial. BJOG: an international Journal of Obstetrics & Gynaecology 31 January 2020; doi: 10.1111/1471-0528.16068
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