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Oral Titrated Misoprostol for Induction of Labour

NCT00992524 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2011-06-23

No results posted yet for this study

Summary

The purpose of this study is to compare effectiveness and safety of an oral titrated solution of misoprostol with vaginal misoprostol for induction of labour with an alive fetus.

Conditions

  • Labor, Induced

Interventions

DRUG

Misoprostol

Oral solution dose will be 20mcg/hour (misoprostol) or 10ml/hour (placebo) in the first six hours with an increase of 20mcg/hour (10ml/hour) of misoprostol or placebo each six hours if labour does not start, until the maximum dose of 80mcg/hour or 40ml/hour in the first 24 hours.

DRUG

Misoprostol

Vaginal tablets will have 25mcg of misoprostol or placebo.

Sponsors & Collaborators

  • Instituto de Saúde Elpidio de Almeida

    collaborator UNKNOWN

  • Universidade Federal do Ceara

    collaborator OTHER

  • Instituto Materno Infantil Prof. Fernando Figueira

    lead OTHER

Principal Investigators

  • Alex SR Souza, Phd student · Professor Fernando Figueira Integral Medicine Institute

  • Melania MR Amorim, Phd · Professor Fernando Figueira Integral Medicine Institute

  • Aurélio AR Costa, PhD · Professor Fernando Figueira Integral Medicine Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • Brazil

Study Locations

More Related Trials

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 NCT00992524 on ClinicalTrials.gov