Preterm Delivery Prevention in Twins With Progesterone

Pregnancies Clinical Trial

Official title: Prevención de Parto Prematuro en Gemelares: Ensayo Aleatorio Con Progesterona Vaginal.

Status Active, not recruiting

Clinical Trial Summary

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%.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pregnancies

• NCT number: NCT01927029
• Study type: Interventional
• Source: Universidad del Desarrollo
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: August 2013
• Completion date: December 2014