Article Name: A Randomized Trial of Progesterone in Women with Bleeding in Early Pregnancy

Journal Title: The New England Journal of Medicine

Publication Year: 2019

Authors: Coomarasamy, et al.

Description:

Progesterone is needed for the maintenance of early pregnancy. Previous smaller studies have suggested that progesterone supplementation may improve outcomes for women experiencing bleeding in early pregnancy. This article is a randomized, double blind controlled trial that compared progesterone with a placebo in women with vaginal bleeding in early pregnancy. 4,153 women were randomly assigned to one of two groups, either receiving 400 mg progesterone (2,079 patients) or placebo (2,074 patients) BID starting from when they presented with the vaginal bleeding though 16 weeks gestation.

Outcomes:

The primary outcome measured was the birth of a live baby after 34 weeks of gestation. The incidence of live births in the progesterone treatment group was 75% (1513 out of 2025 women) and 72% in the placebo group (1459 of 2013 women). The secondary outcome measured was incidence of adverse effects and results showed no significant difference between the two groups.

Conclusion:

In women experiencing vaginal bleeding in early pregnancy, progesterone administration during the first trimester did not result in a significant difference of live births compared to placebo administration.

Limitations

This study only used vaginal preparation of progesterone of 400 mg so results can’t be generalized to other doses or preparations of progesterone. Also, administration of progesterone was stopped at 16 weeks, thus it is unclear but determined unlikely if further administration beyond the 16 weeks could have affected the outcomes. Lastly, the study only included women who had a intrauterine sac visualized on ultrasound so the earlier effects of the use of progesterone prior to visible pregnancy sac cannot be determined.

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