08 May Vaginal Progesterone May Reduce Miscarriages in Women with Bleeding in Early Pregnancy

MedicalResearch.com Interview with:

Prof. Coomarasamy

Prof. Arri Coomarasamy MBChB, MD, FRCOG
Institute of Metabolism and Systems Research
Professor of Gynaecology
Director of Tommy’s National Centre for Miscarriage Research
University of Birmingham

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Progesterone hormone is known to be essential to maintain a pregnancy. Researchers and clinicians have debated for over 50 years whether progesterone supplementation in women with early pregnancy bleeding could rescue a pregnancy from miscarrying. There were some clinical studies suggesting progesterone could be useful, but the studies were of poor quality and small, so we could not be certain.

So the current study, called the PRISM trial, was conducted using very sound methods and on a large population of women, in fact over 4000 women in the UK, to produce a definitive answer to this question. Overall, there were more babies in the group of women given progesterone compared with the group of women given the dummy placebo tablets, but there was statistical uncertainty in this finding.

However, when we looked at the sub-population of women who were at high risk of miscarriage because of not only bleeding in early pregnancy but also having a history of previous miscarriage, we found progesterone was shown to have clear benefit. This is a hugely important finding as there is now a treatment option to women with early pregnancy bleeding and a history of previous miscarriages.

MedicalResearch.com: What should readers take away from your report?

Response: That if they have bleeding in early pregnancy and a history of previous miscarriage, vaginal progesterone treatment from the time of bleeding to 16 weeks of pregnancy can be beneficial in increasing the chances of live birth. 

MedicalResearch.com: What recommendations do you have for future research as a result of this work?

Response: We will need to follow up the babies in the clinical trial to childhood to understand the longer term effect of progesterone treatment. We are in the process of organising this follow up study.

MedicalResearch.com: Is there anything else you would like to add? 

Response: No disclosures. Professor Arri Coomarasamy, University of Birmingham and the Tommy’s National Centre for Miscarriage Research. 

Citation:

A Randomized Trial of Progesterone in Women with Bleeding in Early Pregnancy

Arri Coomarasamy, M.B., Ch.B., M.D., F.R.C.O.G., Adam J. Devall, B.Med.Sci., Ph.D., Versha Cheed, M.Sc., Hoda Harb, M.B., Ch.B., Ph.D., Lee J. Middleton, B.Sc., Ioannis D. Gallos, D.M.S., M.D., Helen Williams, B.Sc., Abey K. Eapen, M.D., Ph.D., Tracy Roberts, Ph.D., R.G.N., Chriscasimir C. Ogwulu, Ph.D., Ilias Goranitis, Ph.D., Jane P. Daniels, M.Med.Sci., Ph.D., et al.
May 9, 2019
N Engl J Med 2019; 380:1815-1824
DOI: 10.1056/NEJMoa1813730

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Last Updated on May 8, 2019 by Marie Benz MD FAAD