Preterm Delivery Prevention in Twins With Progesterone

• Status: Unknown status
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: Female

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%.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universidad del Desarrollo
• Collaborators: Hospital Padre Hurtado; Hospital San Borja-Arriaran
• Treatments: Progesterone

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.