Updated guidance for the use of progesterone to prevent miscarriage

Updated guidance for the use of progesterone to prevent miscarriage

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Proov started this petition to American College of Obstetricians and Gynecologists

The Jan 30th, 2020 publication of the American Journal of Obstetrics & Gynecology presented evidence for use of progesterone to prevent miscarriage. The final guidance to physicians was to "offer women with vaginal bleeding and a history of 1 or more previous miscarriage(s) a course of treatment with vaginal micronized progesterone 400 mg twice daily, started at the time of presentation with vaginal bleeding" The guidance states that clinical history of miscarriage is needed to profile patients who may have a high risk of progesterone-related problems since no accurate endometrial test exists to identify women at risk for pregnancy loss. An accurate endometrial test may allow more precise targeting of patients who may benefit from progesterone treatment and ultimately reduce the number of losses women endure.

Today we present evidence of a non-invasive endometrial test that physicians can use to determine if a patient is at risk for a pregnancy loss, even before she suffers a single miscarriage. Proov PdG tests are urine-based tests that assess progesterone production in the luteal phase (via progesterone metabolite pregnanediol glucuronide) during the implantation window (7-10 days after ovulation). In our clinical study (NCT05033366), we analyzed the PdG levels of 54 pregnant women during the 7-10 day implantation window. Of the 54 pregnancies, 35 of them showed 3 or more positive PdG levels during the implantation window with a first-trimester miscarriage rate of only 14.3% (5/35). However, in pregnancies where PdG levels were below the Proov PdG test threshold (5 ug/ml) 2 or more days during the implantation window, the miscarriage rate increased significantly to 89.4% (17/19). Additionally, our study also showed 8 women in which PdG levels were low, were started on luteal phase progesterone support, and went on to have positive PdG levels and a successful pregnancy.

Therefore, by monitoring PdG levels throughout the implantation window, physicians can determine which patients are at risk for luteal phase insufficiency and treat said patients, thereby decreasing the need to use miscarriage as a clinical marker for offering progesterone support.

This petition is to ask that the ACOG add PdG testing into their clinical assessment to determine which patients are at risk for miscarriage due to poor luteal phase health. Our clinical research has shown that this type of non-invasive, accessible testing decreases miscarriage rates by 75.2%, potentially saving women from additional unsuccessful conception cycles.

Photo credit: @miscarriagedoula (Arden Cartrette)

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