Vaginal progesterone does not lessen preterm birth for high-risk women

Reference

Crowther CA, Ashwood P, McPhee AJ, et al, for the PROGRESS Study Group. Vaginal progesterone pessaries for pregnant women with a previous preterm birth to prevent neonatal respiratory distress syndrome (the PROGRESS Study): A multicentre, randomised, placebo-controlled trial. PLoS Med 14(9): e1002390.

Synopsis

This study was conducted in 787 pregnant women with a history of preterm birth at less than 37 weeks' recruited from 39 Australian, New Zealand, and Canadian hospitals. The women were randomized, using concealed allocation, to receive daily treatment with vaginal progesterone 100 mg daily or placebo starting at 20 weeks' gestation. Cervical length was not considered in this study. Using intention-to-treat analysis, the proportion of infants born before 37 weeks was similar in both groups: 38.2% versus 38.7%. More important, the incidence of neonatal respiratory distress as defined by the need for oxygen or respiratory support in the first 6 hours of life, was similar in both treatment groups: 10.2% versus 10.6% (P = NS). The severity of neonatal respiratory disease, if present, was similar among the 2 groups. Nearly 9% of women did not start treatment or forgot to use it 3 or more times per week.