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

Phase 3

Completed

• Conditions: Induction of Labour

• Registration Number: NCT00299754
• Lead Sponsor: KK Women's and Children's Hospital

Brief 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.

Study Timeline

• Study Start: 2003-01
• Study Completion: 2004-12
• Status Verified: 2005-06
• Study First Submitted: 2006-03-06
• Study First Submitted QC: 2006-03-06
• Last Update Submitted: 2006-03-06
• Study First Posted: 2006-03-07
• Last Update Posted: 2006-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 171

Inclusion Criteria

• singleton pregnancy, cephalic presentation, gestation greater than 37 completed weeks, no known contraindication to vaginal delivery, and Bishop score≤5.

Exclusion Criteria

• previous caesarean section or other uterine surgery, significant maternal medical/obstetric complication in pregnancy (such as severe pre-eclampsia, significant antepartum haemorrhage), antepartum evidence of fetal compromise (such as fetal growth restriction), previous attempt at cervical priming, contraindication to receiving prostaglandins, including asthma and glaucoma.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The primary outcome was the number of women who achieved favourable mBS>6 or active labour by Day 2.

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes were time interval from insert to active labour or delivery, abnormal uterine activity, delivery method and adverse neonatal outcome.

Trial Locations

Locations (1)

National University Hospital; 🇸🇬 Singapore, Singapore