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

• Status: Completed
• Trial end date: 2004-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: KK Women's and Children's Hospital
• Collaborator: National Healthcare Group, Singapore
• Treatments: Dinoprostone; Misoprostol

Criteria

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.