Hormone therapy for women who experience recurrent miscarriage

Author(s): Jesslyn Thay , Date: 25 November 2021

Progesterone hormone therapy has been recently recommended by NICE for the treatment of pregnant mothers who have experienced recurring miscarriages.

The drug has been shown in trials to reduce the risk of miscarriage in women who have previously experienced multiple miscarriages and are bleeding in the early stages of pregnancy.

NICE guidelines recommend that women can be offered 400mg of micronized progesterone twice daily until 16 weeks of pregnancy – if they are eligible for the treatment.

The NICE guidance however, does not recommend progesterone treatment for women who have vaginal bleeding in early pregnancy but have not had a previous miscarriage or women who have had one or more previous miscarriages but don’t have any vaginal bleeding during early pregnancy.

The meta-analysis conducted by Tommy’s National Centre for Miscarriage Research , found that the daily supplementation of progesterone hormone was successful in reducing miscarriage risk women who have experienced bleeding in early stage pregnancy.

Tommy’s charity said that if the recommendation of progesterone supplementation is available to all eligible women it could help carry to term 8,450 more births each year.

While NICE estimates that roughly 1,200 women with prior miscarriage and bleeding in early pregnancy could be eligible for treatment with progesterone each year.

The progesterone therapy was particularly effective in women who had experienced multiple pregnancy losses, with a 15% increase in the live birth rate.

Women who have experienced 3 or more miscarriages in a row, are said to experience recurrent miscarriage. Sadly, the risk of miscarriage increases after each successive loss, but with progesterone supplementation the risk is reduced.

However, NICE mentioned that although there is no evidence of harm to the mother or baby from the use of progesterone, the evidence is insufficient in ruling out the possibility of rare adverse events.

The Tommy’s charity Chief Executive Jane Brewin said: “We hear from women who were denied progesterone treatment when they should have been eligible, simply because their doctor wasn't familiar with it, so we hope NICE’s recommendation will help end some of these inequalities in miscarriage care that add more pain to an already unbearable experience." 

The new research. and subsequent changes to NICE guidelines contradict previous findings from the PROMISE trial. The evidence in 2015 produced a clear result, that Progesterone supplements in the first trimester of pregnancy did not improve outcomes in women with a history of unexplained recurrent miscarriages.

Reference:

Coomarasamy, A., Devall, A., Cheed, V., Harb, H., Middleton, L., Gallos, I., Williams, H., Eapen, A., Roberts, T., Ogwulu, C., Goranitis, I., Daniels, J., Ahmed, A., Bender-Atik, R., Bhatia, K., Bottomley, C., Brewin, J., Choudhary, M., Crosfill, F., Deb, S., Duncan, W., Ewer, A., Hinshaw, K., Holland, T., Izzat, F., Johns, J., Kriedt, K., Lumsden, M., Manda, P., Norman, J., Nunes, N., Overton, C., Quenby, S., Rao, S., Ross, J., Shahid, A., Underwood, M., Vaithilingam, N., Watkins, L., Wykes, C., Horne, A. and Jurkovic, D., 2019. A Randomized Trial of Progesterone in Women with Bleeding in Early Pregnancy. New England Journal of Medicine, 380(19), pp.1815-1824. https://www.nejm.org/doi/full/10.1056/NEJMoa1813730

Further reading:

https://www.miscarriageassociation.org.uk/research/the-promise-trial/

https://www.tommys.org/about-us/charity-news/prism-trial-bleeding-early-pregnancy-and-miscarriage