Published: 31 January 2020
Giving progesterone to women with early pregnancy bleeding and a history of miscarriage could lead to 8,450 more babies being born each year, according to researchers funded by NIHR.
Researchers at the University of Birmingham and Tommy's National Centre for Miscarriage have published two new studies evidencing both the scientific and economic advantages of giving a course of self-administered twice daily progesterone pessaries to women from when they first present with early pregnancy bleeding up until 16 weeks of pregnancy to prevent miscarriage.
Progesterone is a hormone that is naturally secreted by the ovaries and placenta in early pregnancy and is vital to the attainment and maintenance of healthy pregnancies.
Now the experts are calling for progesterone to be offered as standard in the NHS for women with early pregnancy bleeding and a history of miscarriage after their growing body of 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 Gynecology examines the findings of two major clinical trials – PROMISE and PRISM - both funded by NIHR's Health Technology Assessment (HTA) Programme.
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’ (i.e., three or more miscarriages) – with a 15% increase in the live birth rate in the progesterone group compared to the placebo group.
The second of the new studies, 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 on average £204 per pregnancy.
Arri Coomarasamy, Professor of Gynaecology at the University of Birmingham and Director of Tommy’s National Centre for Miscarriage Research, and Chief Investigator of the PRISM trial, said:
“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 United Kingdom, we estimate that implementing this treatment strategy would result in an additional 8,450 live births per year."
More information on the PRISM and the PROMISE trials studies is available on the NIHR Funding Awards Website.