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Preterm Delivery Prevention in Twins With Progesterone

Information source: Universidad del Desarrollo
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pregnancies

Intervention: Progesterone (Drug); Placebo (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Universidad del Desarrollo

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 Details

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

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

Primary outcome: Preterm delivery <34 weeks

Secondary outcome: Preterm delivery <37 weeks

Eligibility

Minimum age: 14 Years. Maximum age: 45 Years. Gender(s): Female.

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.

Locations and Contacts

Additional Information

Starting date: August 2013
Last updated: August 20, 2013

Page last updated: August 23, 2015

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