Labour Induction With Misoprostol, Dinoprostone and Bard Catheter

NCT00602095 | Completed Phase 3 DMC

• 2 other identifiers: LMS2007KS2007
• Study Type: interventional
• Target: 592
• Locations: 0 countries
• Sites: N/A

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

Conditions

Pregnancy

Keywords

Labor induction; cervical ripening; misoprostol; dinoprostone; balloon catheter; prostaglandin

Outcome Measures

Primary Outcomes (1)

• Time from treatment start to delivery

  At delivery

Study Arms (3)

1

EXPERIMENTAL

Labour induction with misoprostol

Drug: misoprostol

2

ACTIVE COMPARATOR

Labour induction with dinoprostone

Drug: dinoprostone

3

EXPERIMENTAL

Labour induction with bard

Device: Bard Catheter (balloon catheter)

Interventions

misoprostol DRUG

0.025mg tablet vaginally every 4 hour until progress

Also known as: Cytotec, one quarter of a 0.100mg tablet

1

dinoprostone DRUG

2mg vaginal gel every 6 hours until progress

Also known as: Minprostin

2

Bard Catheter (balloon catheter) DEVICE

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

Also known as: Bard Catheter

3

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Karolinska University Hospital: lead

Related Publications (1)

• de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.

  PMID: 36996264 DERIVED

MeSH Terms

Interventions

Misoprostol; Tablets; Dinoprostone; dinoprost tromethamine

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Dosage Forms; Pharmaceutical Preparations; Prostaglandins E

Study Officials

• Lena Marions, MD PhD

  Karolinska University Hospital Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 2, 2008
• First Posted: January 28, 2008
• Study Start: December 1, 2004
• Primary Completion: March 1, 2007
• Study Completion: March 1, 2007
• Last Updated: January 28, 2008

Record last verified: 2008-01