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Vaginally Administered Versus Per Oral Misoprostol in Induction of Labour

NCT02539199 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2018-04-18

No results posted yet for this study

Summary

The purpose of this study is to investigate the effectiveness and safety of vaginally administered misoprostol (Misodel) versus per orally administered misoprostol (Cytotec) in induction of labour in nulliparous women.

Conditions

  • Labour Induction

Interventions

DRUG

Misoprostol, modified-release pessary

Misoprostol pessary (7 ug/h) placed in vaginal fornix until labour is induced or maximum 24 hours

DRUG

Misoprostol, per-oral tablets

First day: 50 ug PO in every 4 hours maximum 3 times per day. Second day: 100 ug PO in every 4 hours maximum 3 times per day. Third day: 50 ug vaginally in every 4 hours maximum 3 times per day or until labour is induced.

Sponsors & Collaborators

  • Helsinki University Central Hospital

    collaborator OTHER

  • Oulu University Hospital

    collaborator OTHER

  • Tampere University Hospital

    lead OTHER

Principal Investigators

  • Kati Tihtonen, PhD, MD · Tampere University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2018-03-02
Completion
2018-03-02

Countries

  • Finland

Study Locations

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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 NCT02539199 on ClinicalTrials.gov