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Prophylactic Administration of Natural Progesterone in the Prevention of Preterm Delivery in Twin Pregnancies

NCT01031017 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 390

Last updated 2014-12-04

No results posted yet for this study

Summary

Twin pregnancies are at substantial increased risk of preterm delivery. Prophylactic administration of progesterone in singleton pregnancies at risk of preterm delivery has been shown to be effective in reducing the rate of such complication. The aim of this study is to investigate the effect of prophylactic administration of natural progesterone in twin pregnancies on the rate of preterm births.

Conditions

  • Preterm Delivery

Interventions

DRUG

progesterone

ovules, 200mg per vagina, once a day from 18 weeks

DRUG

placebo

placebo

Sponsors & Collaborators

  • University of Sao Paulo

    lead OTHER

Principal Investigators

  • Maria Brizot, PhD · Department of Obstetrics, São Paulo University Medical School

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2014-05-31
Completion
2014-06-30

Countries

  • Brazil

Study Locations

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Entities

Drugs

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 NCT01031017 on ClinicalTrials.gov