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OpenTrials
Completed

NCT Number: NCT00602095

Labour Induction With Misoprostol, Dinoprostone and Bard Catheter

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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Key information

Conditions

Pregnancy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

  • Previous cesarean section
  • signs of infection
  • immediate need for delivery
  • any contraindication for vaginal delivery

Treatment and study plan

Misoprostol

Drug

0.025mg tablet vaginally every 4 hour until progress

Other names: Cytotec, one quarter of a 0.100mg tablet

Dinoprostone

Drug

2mg vaginal gel every 6 hours until progress

Other names: Minprostin

Bard Catheter (balloon catheter)

Device

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

Other names: Bard Catheter

Primary outcomes

  1. Time from treatment start to delivery

    Time frame: At delivery

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Registry information

Official study title

A Randomised Comparison Between Intravaginal Dinoprostone Intravaginal Misoprostol and Transcervical Balloon Catheter for Labour Induction

Acronym: LI

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Jan 28, 2008
Registry last updated
Jan 28, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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