Prevención de Parto Prematuro en Gemelares: Ensayo Aleatorio Con Progesterona Vaginal.
Overview
- Phase
- Phase 4
- Intervention
- Progesterone
- Conditions
- Pregnancies
- Sponsor
- Universidad del Desarrollo
- Enrollment
- 213
- Primary Endpoint
- Preterm delivery <34 weeks
- Last Updated
- 12 years ago
Overview
Brief 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%.
Investigators
Masami Yamamoto
MD
Clinica Alemana de Santiago
Eligibility Criteria
Inclusion Criteria
- •Monochorionic or Dichorionic twin pregnancies
- •18 weeks to 24 weeks at inclusion.
Exclusion Criteria
- •Cerclage before inclusion
- •Contractions, rupture of the membranes, cervix dilation,
- •Short cervix (15mm or 20mm if there is history of preterm delivery
- •Monoamniotic twins, Major malformation, Selective IUGR, TRAP, TTTS.
- •Younger than 14 years.
Arms & Interventions
Progesterone
Daily administration of vaginal progesterone, 180mg, in gel, from 18 weeks to 34 weeks.
Intervention: Progesterone
Placebo
Placebo Gel, for daily use from 18 weeks to 34 weeks.
Intervention: Placebo
Outcomes
Primary Outcomes
Preterm delivery <34 weeks
Time Frame: 14 months
Spontaneous labor under 34 weeks.
Secondary Outcomes
- Preterm delivery <37 weeks(14 months)