NICE guideline “Ectopic pregnancy and miscarriage”: new changes and importance for the clinicist

Review press release

Authors

  • -

DOI:

https://doi.org/10.18370/2309-4117.2021.62.48-52

Keywords:

UK National Institute for Health and Care Excellence, clinical guidelines, miscarriage, progesterone

Abstract

The purpose of this publication is to summarize the current data on the effectiveness of progestogens in patients with threatened miscarriage (vaginal bleeding in the first trimester of pregnancy) and to review the updated UK National Institute for Health and Care Excel (NICE) clinical guidelines on ectopic pregnancy and miscarriage.
In accordance with the opinion of the Cochrane Society experts and the updated NICE clinical guidelines for 2021, vaginal progesterone at a dose of 800 mg/day is the only intervention that has been shown to be effective in increasing live births compared to placebo for women with one or more previous miscarriages and early vaginal bleeding (relative risk 1.08, 95% confidence interval 1.02–1.15, high certainty evidence). Upon confirmation of fetal heartbeat, this treatment should be extended until 16 weeks of gestation.
There is still uncertainty over the effectiveness and safety of alternative progestogen treatments (as dydrogesterone) for threatened and recurrent miscarriage. There is also no evidence of benefit of any other preparations or doses of progesterone in patients at risk of miscarriage.

References

  1. NICE. Ectopic pregnancy and miscarriage: diagnosis and initial management. NICE Guideline (24th November 2021). Available from: [https://www.nice.org.uk/guidance/ng126].
  2. Coomarasamy, A., Devall, A.J., Cheed, V., et al. “A randomized trial of progesterone in women with bleeding in early pregnancy (PRISM).” N Engl J Med 380 (2019): 1815–24.
  3. Devall, A.J., Coomarasamy, A. “Sporadic pregnancy loss and recurrent miscarriage.” Best Pract Res Clin Obstet Gynaecol 69 (2020): 30–9. DOI: 10.1016/j.bpobgyn.2020.09.002
  4. Okeke Ogwulu, C.B., et al. “The cost-effectiveness of progesterone in preventing miscarriages in women with early pregnancy bleeding: an economic evaluation based on the PRISM trial.” BJOG 127.6 (2020): 757–67.
  5. Royal College of Obstetricians and Gynaecologists. Progesterone could prevent 8,450 miscarriages a year, finds new research (31 Jan 2020). Available from: [https://www.rcog.org.uk/en/news/progesterone-could-prevent-8450-miscarriages-a-year-finds-new-research/].
  6. Devall, A.J., Papadopoulou, A., Podesek, M., et al. “Progestogens for preventing miscarriages: a network meta-analysis.” Cochrane Database of Systematic Reviews 4.4 (2021): CD013792.
  7. Coomarasamy, A., et al. “Sporadic miscarriage: effective care to provide evidence.” The Lancet 397.10285 (2021): 1668–74.
  8. Koren, G., Barer, Y., Kaplan, Y.C. “Fetal safety of medications used in treating infertility.” Expert Rev Clin Pharmacol 13.9 (2020): 991–1000. DOI: 10.1080/17512433.2020.1803738
  9. Devall, A., Gallos, I., Khalaf, Y., et al. “Re: Effect of progestogen for women with threatened miscarriage: a systematic review and meta-analysis. (First comment on BJOG-19-1550.R1)”. Authorea May 22 (2020). DOI: 10.22541/au.159015493.35679779
  10. Li, L., Zhang, Y., Tan, H., et al. “Effect of progestogen for women with threatened miscarriage: a systematic review and meta-analysis.” BJOG 127.9 (2020): 1055–63.
  11. Zaqout, M., et al. “Association between oral intake of dydrogesterone during early pregnancy and congenital heart disease: a case-control study.” Lancet 390.8 (2017). DOI: 10.1016/S0140-6736(17)32059-7
  12. Malherbe, J., Garas, G., Khor, T., MacQuillan, G. “Delayed fulminant hepatic failure from dydrogesterone-related in vitro fertilization therapy requiring liver transplantation during pregnancy.” Am J Case Rep 21 (2020): e925690.
  13. Rode, L., et al. “Prevention of preterm delivery in twin gestations (PREDICT): a multicenter, randomized, placebo-controlled trial on the effect of vaginal micronized progesterone.” Ultrasound Obstet Gynecol 38 (2011): 272–80.
  14. Fronseca, E.B., et al. “Progesterone and the Risk of Preterm Birth among Women with a Short Cervix.” N Engl J Med 357 (2007): 462–9.
  15. Norman, J.E., et al. “Vaginal progesterone prophylaxis for preterm birth (the OPPTIMUM study): a multicentre, randomised, double-blind trial.” Lancet 387.10033 (2016): 2106–16.
  16. Rehal, А., et al. “Early vaginal progesterone versus placebo in twin pregnancies for the prevention of spontaneous preterm birth: a randomized, double-blind trial.” AJOG 224.1 (2021): 86Е1-86E19.
  17. Coomarasamy, А., et al. “A Randomized Trial of Progesterone in Women with Recurrent Miscarriages.” NEJM 373 (2015): 2141–48.

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Published

2021-12-29

How to Cite

-, .-. (2021). NICE guideline “Ectopic pregnancy and miscarriage”: new changes and importance for the clinicist: Review press release. REPRODUCTIVE ENDOCRINOLOGY, (62), 48–52. https://doi.org/10.18370/2309-4117.2021.62.48-52

Issue

No. 62 (2021)

Section

Treatment of infertility and pregnancy

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