Progesterone for the Prevention of Miscarriage and Preterm Birth in Women With First Trimester Bleeding: PREEMPT Trial
Status:
Completed
Trial end date:
2021-02-01
Target enrollment:
Participant gender:
Summary
Miscarriages and preterm births are common and serious events affecting women, families, and
healthcare systems on many levels. One of the risk factors for miscarriage and preterm birth
is bleeding in the first trimester of pregnancy. Progesterone, a hormone that plays a key
role during pregnancy, has been proposed as a possible medication to be used in pregnancy to
prevent miscarriage and preterm birth among women who have bleeding in their first trimester
of pregnancy. Unfortunately, unless sound clinical evidence is obtained through a clinical
trial, whether or not progesterone can indeed prevent miscarriage and preterm birth remains
uncertain and thus is not a recommended treatment in women with early pregnancy bleeding. The
purpose of our study is to evaluate the effect of progesterone for the prevention of
miscarriage and preterm birth among women with early pregnancy bleeding. We will carry out a
clinical trial in which 850 women will be randomized to receive either progesterone
supplementation (425 women) or a similarly appearing placebo (425 women) and the outcome of
their pregnancy will be compared.