Labour Induction With Misoprostol, Dinoprostone and Bard Catheter - Full Text View

Sponsor:	Karolinska University Hospital
Information provided by:	Karolinska University Hospital
ClinicalTrials.gov Identifier:	NCT00602095

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 III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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:

Drug Information available for: Misoprostol Dinoprostone

U.S. FDA Resources

Further study details as provided by Karolinska University Hospital:

Primary Outcome Measures:

Time from treatment start to delivery [ Time Frame: At delivery ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:	18 Years and older
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00602095

Sponsors and Collaborators

Karolinska University Hospital

Investigators

Principal Investigator:

Lena Marions, MD PhD

Karolinska University Hospital Institute

More Information

No publications provided

Responsible Party:	Lena Marions MD PhD, Karolinska University Hospital
ClinicalTrials.gov Identifier:	NCT00602095 History of Changes
Other Study ID Numbers:	LMS2007, KS2007
Study First Received:	January 2, 2008
Last Updated:	January 15, 2008
Health Authority:	Sweden: Regional Ethical Review Board

Keywords provided by Karolinska University Hospital:

Labor induction
cervical ripening
misoprostol

dinoprostone
balloon catheter
prostaglandin

Additional relevant MeSH terms:

Dinoprostone
Misoprostol
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions

Therapeutic Uses
Anti-Ulcer Agents
Gastrointestinal Agents
Abortifacient Agents, Nonsteroidal
Abortifacient Agents

ClinicalTrials.gov processed this record on February 09, 2012