NCT00299754

Trial Of Misoprostol And Dinoprostone Vaginal Pessaries for Cervical Priming (TROMAD Study)

The Randomised-Controlled Trial Of Misoprostol And Dinoprostone Vaginal Pessaries for Cervical Priming (TROMAD Study)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 171 (planned)
• Sponsor: KK Women's and Children's Hospital · Other Government
• Sex: Female
• Age: 0 Years
• Healthy volunteers: Accepted

Summary

Most studies of labour induction with misoprostol used doses higher than 25mg and intervals of 3-4 hours. We studied a low-dose regime of 25mg misoprostol and compared its efficacy as single dose or double dose with dosing interval of 6 hours to our current regime of 3 mg dinoprostone pessary.

Detailed description

171 women with singleton term pregnancies and modified Bishop score (mBS) ≤ 5 were recruited and randomized into 3 arms: current dinoprostone regime, double dose misoprostol or single dose misoprostol. The primary outcome was the number of women who achieved favourable mBS\>6 or active labour by Day 2. Secondary outcomes were time interval from insert to active labour or delivery, abnormal uterine activity, delivery method and adverse neonatal outcome.

Conditions

• Induction of Labour

Interventions

Type	Name	Description
DRUG	Misoprostol

Timeline

• Start date: 2003-01-01
• Completion: 2004-12-01
• First posted: 2006-03-07
• Last updated: 2006-03-07

Locations

1 site across 1 country: Singapore