Preterm Delivery Prevention in Twins With Progesterone

Phase 4

• Conditions: Pregnancies
• Interventions: Drug: Placebo; Drug: Progesterone

• Registration Number: NCT01927029
• Lead Sponsor: Universidad del Desarrollo

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%.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-08
• Study Start: 2013-08
• Study First Submitted: 2013-08-19
• Study First Submitted QC: 2013-08-20
• Last Update Submitted: 2013-08-20
• Study First Posted: 2013-08-21
• Last Update Posted: 2013-08-21
• Primary Completion: 2014-10
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 213

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo Gel, for daily use from 18 weeks to 34 weeks.
Progesterone	Progesterone	Daily administration of vaginal progesterone, 180mg, in gel, from 18 weeks to 34 weeks.

Primary Outcome Measures

Name	Time	Method
Preterm delivery <34 weeks	14 months	Spontaneous labor under 34 weeks.

Secondary Outcome Measures

Name	Time	Method
Preterm delivery <37 weeks	14 months	Spontaneous delivery under 37 weeks