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Low-dose Vaginal Misoprostol Versus Vaginal Dinoprostone Insert for Induction of Labor

NCT03744364 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2018-11-16

No results posted yet for this study

Summary

Purpose:

To compare the efficacy and safety of low-dose protocol of vaginal misoprostol and vaginal dinoprostone insert for induction of labor in women with post-term pregnancies.

Methods:

The investigators designed a prospective, randomized, open-labeled, blinded for the end-point evaluators trial including women of at least 41 weeks of gestational age with uncomplicated singleton pregnancies and Bishop score lower than 6. Participants were randomized into dinoprostone or misoprostol groups in a 1:1 ratio. Baseline maternal data and perinatal outcomes were recorded for statistical analysis. Successful vaginal delivery within 24 hours was the primary outcome variable.

Conditions

  • Induced Labor
  • Cervical Ripening
  • Obstetric Labor
  • Pregnancy

Interventions

DRUG

Misoprostol 25 mcg

To determine efficacy and safety of vaginal 'Misoprostol 25 mcg' every 4 hours with a maximum of 6 doses for induction of labor.

DRUG

Dinoprostone 10mg

To determine efficacy and safety of 'Dinoprostone 10mg' vaginal insert for induction of labor.

Sponsors & Collaborators

  • Hospital Miguel Servet

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-06-01
Primary Completion
2017-10-20
Completion
2017-11-01

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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 NCT03744364 on ClinicalTrials.gov