"A Randomized Trial of Progesterone in Women with bleeding in Early Pregnancy"

Presented by Robert Chasuk, MD


This research, "A Randomized Trial of Progesterone in Women with Bleeding in Early Pregnancy" was discussed in November Journal Club 2019.

You can download a note-taking sheet with some question prompts to consider when evaluating research methods at https://iirrm.org/wp-content/uploads/2018/12/Methods-questions.pdf."


Background: Bleeding in early pregnancy is strongly associated with pregnancy loss. Progester- one is essential for the maintenance of pregnancy. Several small trials have sug- gested that progesterone therapy may improve pregnancy outcomes in women who have bleeding in early pregnancy.

Methods:  We conducted a multicenter, randomized, double-blind, placebo-controlled trial to evaluate progesterone, as compared with placebo, in women with vaginal bleeding in early pregnancy. Women were randomly assigned to receive vaginal suppositories containing either 400 mg of progesterone or matching placebo twice daily, from the time at which they presented with bleeding through 16 weeks of gesta- tion. The primary outcome was the birth of a live-born baby after at least 34 weeks of gestation. The primary analysis was performed in all participants for whom data on the primary outcome were available. A sensitivity analysis of the primary outcome that included all the participants was performed with the use of multiple imputation to account for missing data.

Results:  A total of 4153 women, recruited at 48 hospitals in the United Kingdom, were randomly assigned to receive progesterone (2079 women) or placebo (2074 women). The percentage of women with available data for the primary outcome was 97% (4038 of 4153 women). The incidence of live births after at least 34 weeks of gesta- tion was 75% (1513 of 2025 women) in the progesterone group and 72% (1459 of 2013 women) in the placebo group (relative rate, 1.03; 95% confidence interval [CI], 1.00 to 1.07; P=0.08). The sensitivity analysis, in which missing primary outcome data were imputed, resulted in a similar finding (relative rate, 1.03; 95% CI, 1.00 to 1.07; P=0.08). The incidence of adverse events did not differ signifi- cantly between the groups.

Conclusion: Among women with bleeding in early pregnancy, progesterone therapy administered during the first trimester did not result in a significantly higher incidence of live births than placebo.

(Funded by the United Kingdom National Institute for Health Research Health Technology Assessment program; PRISM Current Con- trolled Trials number, ISRCTN14163439.)

Referenced Article: Coomarasamy et al. (2019) A Randomized Trial of Progesterone in Women with Bleeding in Early Pregnancy. New England Journal of Medicine. 380. 1815-1824. 10.1056/NEJMoa1813730.

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Journal Club sessions provide a critical appraisal of published research relevant to the field of restorative reproductive medicine. These sessions are designed to increase providers’ competence to critically evaluate research by increasing their knowledge of the scientific method, research design, and common biases. Improvements in knowledge and competence will translate into improvements in clinician performance as they use their understanding of research to provide better care and communication to their patients and apply the results from research to clinical practise.

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