Labour Induction With Misoprostol, Dinoprostone and Bard Catheter (LI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00602095
Recruitment Status : Completed
First Posted : January 28, 2008
Last Update Posted : January 28, 2008
Information provided by:
Karolinska University Hospital

Brief 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

Condition or disease Intervention/treatment Phase
Pregnancy Drug: misoprostol Drug: dinoprostone Device: Bard Catheter (balloon catheter) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 592 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomised Comparison Between Intravaginal Dinoprostone Intravaginal Misoprostol and Transcervical Balloon Catheter for Labour Induction
Study Start Date : December 2004
Actual Primary Completion Date : March 2007
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Labour induction with misoprostol
Drug: misoprostol
0.025mg tablet vaginally every 4 hour until progress
Other Name: Cytotec, one quarter of a 0.100mg tablet

Active Comparator: 2
Labour induction with dinoprostone
Drug: dinoprostone
2mg vaginal gel every 6 hours until progress
Other Name: Minprostin

Experimental: 3
Labour induction with bard
Device: Bard Catheter (balloon catheter)
Intracervical balloon catheter positioned above internal cervical os and filled with sterile water. Removed when cervix was dilated
Other Name: Bard Catheter

Primary Outcome Measures :
  1. Time from treatment start to delivery [ Time Frame: At delivery ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00602095

Sponsors and Collaborators
Karolinska University Hospital
Principal Investigator: Lena Marions, MD PhD Karolinska University Hospital Institute

Responsible Party: Lena Marions MD PhD, Karolinska University Hospital Identifier: NCT00602095     History of Changes
Other Study ID Numbers: LMS2007
First Posted: January 28, 2008    Key Record Dates
Last Update Posted: January 28, 2008
Last Verified: January 2008

Keywords provided by Karolinska University Hospital:
Labor induction
cervical ripening
balloon catheter

Additional relevant MeSH terms:
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents