Progesterone In Early Pregnancy Not Effective in Preventing Miscarriage

Arri Coomarasamy, MBChB, MD, FRCOG Professor of Gynaecology and Reproductive Medicine University of Birmingham

Prof. Coomarasamy Interview with:
Arri Coomarasamy, MBChB, MD, FRCOG
Professor of Gynaecology and Reproductive Medicine
University of Birmingham

Medical Research: What is the background for this study? What are the main findings?

Professor Coomarasamy: Progesterone is a natural hormone that is essential to maintain a healthy pregnancy, and more than 60 years ago clinicians and researchers began to ask if progesterone supplementation in the first trimester of pregnancy could help to reduce the risk of miscarriage for women with a history of recurrent miscarriage. The evidence achieved in some small controlled clinical trials conducted before the PROMISE (progesterone in recurrent miscarriage) trial suggested a benefit from progesterone therapy, but without sufficient certainty to usefully guide clinical practice.

Five years after it began, the PROMISE trial has provided a definitive result. It is clear, it is important, and it is not the result that many anticipated. Our study of more than 800 women with a history of unexplained recurrent miscarriage has shown that those who received progesterone treatment in early pregnancy were no less likely to miscarry than those who received a placebo (or dummy treatment). This was true whatever their age, ethnicity, and medical history.

Medical Research: What should clinicians and patients take away from your report?

Professor Coomarasamy: The findings of the PROMISE trial are bound to come as a disappointment to many thousands of women and couples affected by miscarriage.

They will be especially disheartening to those with repeated miscarriages for which specialist investigations have shown no obvious cause. Many hoped that this research would confirm progesterone as an effective treatment to increase the chance of a ‘take-home’ baby next time. Sadly, it does not.

In the past some clinicians have prescribed progesterone because they hoped it might help their recurrent miscarriage patients and now, along with their patients, they are faced with the evidence that progesterone therapy does not reduce the incidence of repeated pregnancy loss and the considerable distress it causes.

But there are some important positive messages to take away from the study too. Whether they received progesterone or placebo, nearly two thirds of the women participating in the trial had their much-wanted baby. That means there is still a good chance of a healthy pregnancy after unexplained recurrent miscarriage without any treatment at all.

The trial results also showed that there were no significant negative side effects of progesterone treatment for women or for their babies. That is very important information for women taking progesterone for other reasons, such as fertility treatment.

Medical Research: What recommendations do you have for future research as a result of this study?

Professor Coomarasamy: We now know that progesterone treatment in early pregnancy isn’t the answer for women with unexplained recurrent losses. And that means we can direct our efforts to investigating other possibilities to increase the chances of a healthy baby. The PROMISE trial created a solid network of doctors, nurses and midwives across the UK and beyond, all committed to miscarriage research. We will continue to explore and test other treatments that we hope to really reduce the risk of miscarriage.


A Randomized Trial of Progesterone in Women with Recurrent Miscarriages

Arri Coomarasamy, M.B., Ch.B., M.D., Helen Williams, B.Sc., Ewa Truchanowicz, Ph.D., Paul T. Seed, M.Sc., Rachel Small, R.G.N., R.M., Siobhan Quenby, M.D., Pratima Gupta, M.D., Feroza Dawood, M.B., Ch.B., M.D., Yvonne E.M. Koot, M.D., Ruth Bender Atik, B.A., Kitty W.M. Bloemenkamp, M.D., Ph.D., Rebecca Brady, R.N.Dip., M.Sc., T.N.Dip., Annette L. Briley, Ph.D., Rebecca Cavallaro, R.M., R.N., M.Mid., Ying C. Cheong, M.B., Ch.B., M.D., Justin J. Chu, M.D., Abey Eapen, M.D., Ayman Ewies, M.B., Ch.B., M.D., Annemieke Hoek, M.D., Ph.D., Eugenie M. Kaaijk, M.D., Carolien A.M. Koks, M.D., Tin-Chiu Li, M.D., Marjory MacLean, M.D., Ben W. Mol, M.D., Ph.D., Judith Moore, M.R.C.O.G., Jackie A. Ross, M.B., B.S., Lisa Sharpe, R.M.Dip., Jane Stewart, M.B., Ch.B., M.D., Nirmala Vaithilingam, M.D., Roy G. Farquharson, M.D., Mark D. Kilby, M.B., B.S., M.D., Yacoub Khalaf, M.B., B.Ch., M.D., Mariette Goddijn, M.D., Ph.D., Lesley Regan, M.D., and Rajendra Rai, M.D.

N Engl J Med 2015; 373:2141-2148
November 26, 2015DOI: 10.1056/NEJMoa1504927

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Arri Coomarasamy, MBChB, MD, FRCOG (2015). Progesterone In Early Pregnancy Not Effective in Preventing Miscarriage