Vaginal progesterone for prevention of preterm delivery in women with twin pregnancy: a randomized controlled trial

Background: The aim of this study is to evaluate the efficacy of vaginal progesterone to prevent preterm delivery in twin pregnancies and its effect on perinatal outcome. Materials and methods: A randomized, open label, controlled trial (NCT02350231) was carried out over 70 women, in three different hospitals in Egypt, between February 2015 and January 2017. All eligible pregnant women with twin pregnancies were randomly allocated in a 1:1 ratio into two groups. Group I (Progesterone group) was dispensed, 400 mg of progesterone through a vaginal pessary, each day at bedtime, from the 28th week of pregnancy until delivery. Group II (Control group) received no treatment other than the normal tonics taken during pregnancy. The two study groups were followed until delivery. The primary outcome was the rate of preterm delivery <37 weeks. Results: No significant differences were observed among both groups of women in terms of delivery <37 weeks (16.9% versus 25.4%; p=0.06) and mode of delivery (vaginal versus cesarean; p=0.31). The mean gestational age at delivery was comparable between both groups (p=0.09). Additionally, no difference, regarding the neonatal outcome, was observed between both groups. Conclusion: Dispensing vaginal progesterone [400 mg] after 28 weeks of gestation does not prevent preterm delivery in twin gestations.