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Labour Induction With Misoprostol, Dinoprostone and Bard Catheter

NCT00602095 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 592

Last updated 2008-01-28

No results posted yet for this study

Summary

This is a randomised study aimed at comparing the currently most frequently used prostaglandin dinoprostone to two other methods, the cheaper and perhaps more effective prostaglandin misoprostol and a transcervical catheter. 592 women were recruited and randomised to one of the three methods. The main outcome measures were time to delivery, rate of instrumental deliveries and maternal neonatal outcome. Our hypothesis was that misoprostol would be superior to the other methods.

The main finding of our trial was that the catheter showed the shortest induction to delivery interval. There were no differences between the two other prostaglandins. No differences in maternal and neonatal outcome was found

Conditions

  • Pregnancy

Interventions

DRUG

misoprostol

0.025mg tablet vaginally every 4 hour until progress

DRUG

dinoprostone

2mg vaginal gel every 6 hours until progress

DEVICE

Bard Catheter (balloon catheter)

Intracervical balloon catheter positioned above internal cervical os and filled with sterile water. Removed when cervix was dilated

Sponsors & Collaborators

  • Karolinska University Hospital

    lead OTHER

Principal Investigators

  • Lena Marions, MD PhD · Karolinska University Hospital Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-12-31
Primary Completion
2007-03-31
Completion
2007-03-31

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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 NCT00602095 on ClinicalTrials.gov