Institute publishes largest study of its kind

The Pope Paul VI Institute publishes largest study of its kind on the safety of progesterone use in pregnancy


A progesterone molecule.

In the December 2015 issue of Issues in Law & Medicine, the Pope Paul VI Institute published the largest research study of its kind on fetal safety with the use of progesterone in pregnancy. The authors of this study were Thomas W. Hilgers, MD, the Director of the Pope Paul VI Institute, and Associate Medical Consultants Catherine E. Keefe, MD and Kristina A. Pakiz, MD.

This study covered a total of 1,310 pregnancies that had been supported by bioidentical, or naturally-occurring, progesterone and the outcome of those pregnancies based on any problems that may have occurred in the babies (from 1979 – 2014). The results were compared to a second group of 453 pregnancies that did not receive progesterone during the course of their pregnancies. The group receiving progesterone was considered to be at a higher risk for problems than the control group primarily because of the large number of patients who had reproductive abnormalities in that particular group. The overall incidence of fetal anomalies observed in patients who took progesterone and those who did not take progesterone was identical: 2.2%. While there have been other studies on the fetal safety of progesterone, this study’s sample size was 2.5 times larger than any previous study of its kind.

The study concluded that bio-identical progesterone posed no risk of teratogenicity or malformations when used to support pregnancy, either in the early or later days of gestation.

Between 150–200 pregnancies are managed each month at the Pope Paul VI Institute with progesterone support.

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