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.
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.
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 tha
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?”