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The randomised controlled trial of micronised progesterone and dydrogesterone (TRoMaD) for threatened miscarriage.

Publication ,  Journal Article
Siew, JYS; Allen, JC; Hui, CYY; Ku, CW; Malhotra, R; Østbye, T; Tan, TC
Published in: Eur J Obstet Gynecol Reprod Biol
September 2018

UNLABELLED: There has not been conclusive evidence in literature on the efficacy of progestogen in the treatment of threatened miscarriage, although some studies showed benefits. In our centre, threatened miscarriage is treated with either micronised progesterone (MP) or dydrogesterone (DYD). OBJECTIVE: The aim of this study is to compare clinical outcomes of miscarriage, extent of vaginal bleeding at follow-up and side effects between treatment groups. STUDY DESIGN: This study was a prospective parallel-group, open-label, randomized controlled trial. 141 women presenting with threatened miscarriage were randomised to either MP or DYD of which 118 were included in the analysis. Baseline maternal demographics and serum progesterone levels were collected at presentation. Post-treatment bleeding pattern and self-reported side effects were recorded at the follow-up visit (on day 4-10 of treatment). The occurrence of spontaneous miscarriage was ascertained at week 16 of gestation. RESULTS: The population with miscarriage and resolution of bleeding were not statistically different between MP and DYD groups. A significantly higher percentage of women treated with MP reported drowsiness (p = 0.003). After stratification into low and high serum progesterone levels, a significantly higher miscarriage rate was found in the low progesterone group, regardless of treatment type. CONCLUSION: In conclusion, extent of bleeding at day 4-10 and subsequent miscarriage rates were comparable between MP and DYD groups. However, fewer patients treated with DYD reported drowsiness and giddiness. The finding of significantly higher miscarriage rates in women with low progesterone levels despite treatment is an important factor to consider in counselling and prognosticating pregnancy outcomes.

Duke Scholars

Published In

Eur J Obstet Gynecol Reprod Biol

DOI

EISSN

1872-7654

Publication Date

September 2018

Volume

228

Start / End Page

319 / 324

Location

Ireland

Related Subject Headings

  • Uterine Hemorrhage
  • Prospective Studies
  • Progestins
  • Progesterone
  • Pregnancy
  • Obstetrics & Reproductive Medicine
  • Humans
  • Female
  • Dydrogesterone
  • Adult
 

Citation

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ICMJE
MLA
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Siew, J. Y. S., Allen, J. C., Hui, C. Y. Y., Ku, C. W., Malhotra, R., Østbye, T., & Tan, T. C. (2018). The randomised controlled trial of micronised progesterone and dydrogesterone (TRoMaD) for threatened miscarriage. Eur J Obstet Gynecol Reprod Biol, 228, 319–324. https://doi.org/10.1016/j.ejogrb.2018.07.028
Siew, Jia Yun S., John C. Allen, Celene Y. Y. Hui, Chee Wai Ku, Rahul Malhotra, Truls Østbye, and Thiam Chye Tan. “The randomised controlled trial of micronised progesterone and dydrogesterone (TRoMaD) for threatened miscarriage.Eur J Obstet Gynecol Reprod Biol 228 (September 2018): 319–24. https://doi.org/10.1016/j.ejogrb.2018.07.028.
Siew JYS, Allen JC, Hui CYY, Ku CW, Malhotra R, Østbye T, et al. The randomised controlled trial of micronised progesterone and dydrogesterone (TRoMaD) for threatened miscarriage. Eur J Obstet Gynecol Reprod Biol. 2018 Sep;228:319–24.
Siew, Jia Yun S., et al. “The randomised controlled trial of micronised progesterone and dydrogesterone (TRoMaD) for threatened miscarriage.Eur J Obstet Gynecol Reprod Biol, vol. 228, Sept. 2018, pp. 319–24. Pubmed, doi:10.1016/j.ejogrb.2018.07.028.
Siew JYS, Allen JC, Hui CYY, Ku CW, Malhotra R, Østbye T, Tan TC. The randomised controlled trial of micronised progesterone and dydrogesterone (TRoMaD) for threatened miscarriage. Eur J Obstet Gynecol Reprod Biol. 2018 Sep;228:319–324.
Journal cover image

Published In

Eur J Obstet Gynecol Reprod Biol

DOI

EISSN

1872-7654

Publication Date

September 2018

Volume

228

Start / End Page

319 / 324

Location

Ireland

Related Subject Headings

  • Uterine Hemorrhage
  • Prospective Studies
  • Progestins
  • Progesterone
  • Pregnancy
  • Obstetrics & Reproductive Medicine
  • Humans
  • Female
  • Dydrogesterone
  • Adult