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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00602095
First Posted: January 28, 2008
Last Update Posted: January 28, 2008
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.
Information provided by:
Karolinska University Hospital
  Purpose

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 Intervention Phase
Pregnancy Drug: misoprostol Drug: dinoprostone Device: Bard Catheter (balloon catheter) Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Karolinska University Hospital:

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

Enrollment: 592
Study Start Date: December 2004
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00602095


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

Responsible Party: Lena Marions MD PhD, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT00602095     History of Changes
Other Study ID Numbers: LMS2007
KS2007
First Submitted: January 2, 2008
First Posted: January 28, 2008
Last Update Posted: January 28, 2008
Last Verified: January 2008

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

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