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NCT ID: NCT01927029 Active, not recruiting - Pregnancies Clinical Trials

Preterm Delivery Prevention in Twins With Progesterone

Start date: August 2013
Phase: Phase 4
Study type: Interventional

Twin pregnancies have very high preterm delivery rate. Until now, no RCT has proven benefit of progesterone in this population. In contrast, singleton pregnancies are treated with this hormone. The objective is to compare 180mg/day progeterone vaginal gel with 180mg/day with placebo, from 18 weeks to 34 weeks. The sample size was calculated and 213 cases in each group are needed to demonstrate a reduction of preterm delivery <34weeks from 13% to 7%.