Preterm Delivery Prevention in Twins With Progesterone

Phase 4UnknownNCT01927029

Universidad del Desarrollo213 enrolled

Overview

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%.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

213

Conditions

Pregnancies

Interventions

ProgesteroneDRUG

Vaginal progesterone gel 180mg/daily is given from second trimester (18 to 24 weeks) until 34 weeks.

PlaceboDRUG

Eligibility

Sex: FEMALEMin age: 14 YearsMax age: 45 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Preterm delivery <34 weeks

Spontaneous labor under 34 weeks.

Time frame: 14 months

Secondary Outcomes

Preterm delivery <37 weeks

Spontaneous delivery under 37 weeks

Time frame: 14 months

Data from ClinicalTrials.gov

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