Giving progesterone to women with early pregnancy bleeding and a history of miscarriage could lead to 8,450 more babies being born each year, finds new research published today.
Two new studies evidence 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.
Researchers 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 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.
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.
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 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.
Dr Pat O’Brien, Consultant Obstetrician and Vice President of The Royal College of Obstetricians and Gynaecologists, said: “Miscarriage can be a devastating loss for women, their partners and families. We, therefore, welcome the findings from these well researched trials which support the use of progesterone among women with early pregnancy bleeding and a history of miscarriage.
“This treatment offers an increased chance of a successful birth and appears to be cost effective for the NHS, so we hope NICE will consider this important research in their next update of the guidance.
“For women with no prior history of miscarriage, there does not appear to be much benefit of the treatment, and women with concerns about their pregnancy should contact their midwife or early pregnancy unit for care and support. Reassuringly, most women who have had a miscarriage will have a successful pregnancy and birth in the future.”
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.
“The role of first trimester progesterone supplementation in the treatment of pregnancies at high risk of miscarriage is a long standing research question that has been debated in the medical literature for over 60 years.
“Thus far, policy makers have been unable to make evidence-based recommendations on the use of progesterone supplementation to improve outcomes.
“The PRISM and PROMISE Trials found a small but positive treatment effect, dependent on the number of previous miscarriages.
“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?”
Tracy Roberts, Professor of Economics at the University of Birmingham, said: “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.”
For media enquiries, please contact the RCOG press office on +44 (0)20 7045 6773 or email firstname.lastname@example.org
For anyone affected, the Miscarriage Association has useful information and support available on their website.
Charity Tommy’s has information available on miscarriage.
RCOG information leaflet on early miscarriage.
RCOG information leaflet on recurrent and late miscarriage.