Researchers at the University of Birmingham and Tommy’s National Centre for Miscarriage Research 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 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 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 studied 836 women with unexplained recurrent miscarriages at 45 hospitals in the UK and the Netherlands, and found a three percent 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 five percent 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 percent 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 & Gynecology, evaluates the economics of the PRISM trial and, importantly, concludes that progesterone is cost-effective, costing on average £204 per pregnancy.
Meanwhile, an unpublished survey by the University of Birmingham of 130 health care practitioners in the UK found that prior to the results of the PRISM study just 13 percent offered women at threat of miscarriage progesterone, while post publication of the results in the New England Journal of Medicine in May 2019, 75 percent now offer the treatment.
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 percent 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, policymakers 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?”
Arri Coomarasamy, Professor of Gynaecology at the University of Birmingham and Director of Tommy’s National Centre for Miscarriage Research, 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.
“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 policymakers and guideline developers to consider the evidence carefully to make a balanced recommendation.”
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