Overview

This trial is active, not recruiting.

Condition pregnancies
Treatments progesterone, placebo
Phase phase 4
Sponsor Universidad del Desarrollo
Collaborator Hospital Padre Hurtado
Start date August 2013
End date October 2014
Trial size 213 participants
Trial identifier NCT01927029, CAS149

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%.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver)
Primary purpose prevention
Arm
(Experimental)
Daily administration of vaginal progesterone, 180mg, in gel, from 18 weeks to 34 weeks.
progesterone Progendo gel
Vaginal progesterone gel 180mg/daily is given from second trimester (18 to 24 weeks) until 34 weeks.
(Placebo Comparator)
Placebo Gel, for daily use from 18 weeks to 34 weeks.
placebo

Primary Outcomes

Measure
Preterm delivery <34 weeks
time frame: 14 months

Secondary Outcomes

Measure
Preterm delivery <37 weeks
time frame: 14 months

Eligibility Criteria

Female participants from 14 years up to 45 years old.

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.

Additional Information

Official title Prevención de Parto Prematuro en Gemelares: Ensayo Aleatorio Con Progesterona Vaginal.
Trial information was received from ClinicalTrials.gov and was last updated in August 2013.
Information provided to ClinicalTrials.gov by Universidad del Desarrollo.