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Preterm Delivery Prevention in Twins With Progesterone

NCT01927029 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 213

Last updated 2013-08-21

No results posted yet for this study

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%.

Conditions

  • Pregnancies

Interventions

DRUG

Progesterone

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

DRUG

Placebo

Sponsors & Collaborators

  • Hospital Padre Hurtado

    collaborator OTHER

  • Hospital San Borja-Arriaran

    collaborator OTHER

  • Universidad del Desarrollo

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2014-10-31
Completion
2014-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01927029 on ClinicalTrials.gov