Labour Induction With Misoprostol, Dinoprostone and Bard Catheter

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

592 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2007-03-31

Brief Summary

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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

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Detailed Description

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Conditions

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Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Labour induction with misoprostol

Group Type EXPERIMENTAL

misoprostol

Intervention Type DRUG

0.025mg tablet vaginally every 4 hour until progress

2

Labour induction with dinoprostone

Group Type ACTIVE_COMPARATOR

dinoprostone

Intervention Type DRUG

2mg vaginal gel every 6 hours until progress

3

Labour induction with bard

Group Type EXPERIMENTAL

Bard Catheter (balloon catheter)

Intervention Type DEVICE

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

Interventions

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misoprostol

0.025mg tablet vaginally every 4 hour until progress

Intervention Type DRUG

dinoprostone

2mg vaginal gel every 6 hours until progress

Intervention Type DRUG

Bard Catheter (balloon catheter)

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

Intervention Type DEVICE

Other Intervention Names

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Cytotec, one quarter of a 0.100mg tablet Minprostin Bard Catheter

Eligibility Criteria

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Inclusion Criteria

* Full term singleton pregnancy with vertex presentation and with an indication for labour induction.
* Absence of active labour
* Bishop score ≤ 6.
* Normal CTG registration