January 31 2020
Researchers at Tommy’s National Centre for Miscarriage Research and the University of Birmingham say giving progesterone to women with early pregnancy bleeding and a history of miscarriage could lead to 8,450 more babies being born each year.
The team have published 2 new studies showing both the scientific and economic advantages of prescribing a course of progesterone pessaries to women from when they first present with early pregnancy bleeding up until 16 weeks of pregnancy to prevent miscarriage.
The benefits of progesterone
Experts are now calling for progesterone to be offered as standard in the NHS for women with early pregnancy bleeding and a history of miscarriage after their research has found it is both cost-effective and can increase women’s chances of having a baby.
The first of the new studies, published today in the American Journal of Obstetrics and Gynaecology examines the findings of 2 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 studied 836 women with unexplained recurrent miscarriages at 45 hospitals in the UK and the Netherlands and found a 3% higher live birth rate with progesterone, but with substantial statistical uncertainty.
PRISM studied 4,153 women with early pregnancy bleeding at 48 hospitals in the UK and 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.
Is progesterone cost-effective?
The second of the new studies, published in BJOG: an international Journal of Obstetrics & Gynaecology, evaluates the economics of the PRISM trial and, importantly, concludes that progesterone is cost-effective, costing on average £204 per pregnancy.
“Miscarriage is a significant economic burden, costing the UK’s NHS around £350 million per year for the management of miscarriage and complications. Given the distress to women and families associated with miscarriage, and the subsequent resources that might be associated with counselling and close antenatal attention in the subsequent pregnancies of women who experience miscarriage, progesterone is likely to be considered good value for money in preventing miscarriage.”
Tracy Roberts, Professor of Economics at the University of Birmingham
Meanwhile, an unpublished survey by the University of Birmingham of 130 UK healthcare practitioners found that prior to the results of the PRISM study, just 13% offered women at threat of miscarriage progesterone. However, since the publication of the results in the New England Journal of Medicine in May 2019, 75% of healthcare practitioners now offer the treatment.
“Our suggestion is to consider offering to women with early pregnancy bleeding and a history of one or more previous miscarriages a course of treatment of progesterone 400mg twice daily, started at the time of presentation with vaginal bleeding and continued to 16 completed weeks of gestation. In the UK, we estimate that implementing this treatment strategy would result in an additional 8,450 live births per year.
"We believe that women at high risk of having a miscarriage may not need absolute scientific certainty to choose to have a treatment. We recommend that they are informed about the uncertainty around treatment effects, so they can then decide for themselves the right course of action. We now urge policy makers and guideline developers to consider the evidence carefully to make a balanced recommendation.”
Arri Coomarasamy, Director of Tommy’s National Centre for Miscarriage Research and Professor of Gynaecology at the University of Birmingham
I have early pregnancy bleeding. Where can I get this treatment?
If you have early pregnancy bleeding and have had one or more previous miscarriages, you should request progesterone treatment. As many clinicians will not have heard of this very recent research, we have developed a simple and clear infographic that you can bring with you to the doctor that clearly explains the benefits of the treatment.
Read more about the PRISM trial.
Find out more about bleeding in pregnancy.