Faculty of Health Sciences
School of Medicine
Department of Paediatrics
A study to asses the efficacy, safety and tolerability of Prochieve 8% Progesterone Gel
A Phase IIII, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety and tolerability of Prochieve 8% Progesterone Gel in preventing preterm delivery in pregnant women at increased risk for preterm delivery. The primary objective will be to demonstrate a reduction in the frequency of delivery at <31 0/7 weeks gestational age in subjects who have had a previous preterm delivery. Supplemental objectives evaluate the frequency and significant morbidity in infants during the initial hospitalization after birth, number of hospital days from delivery to initial discharge and the neurodevelopment of the babies till the age of two years
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