Status:
COMPLETED
Trial Of Misoprostol And Dinoprostone Vaginal Pessaries for Cervical Priming (TROMAD Study)
Lead Sponsor:
KK Women's and Children's Hospital
Collaborating Sponsors:
National Healthcare Group, Singapore
Conditions:
Induction of Labour
Eligibility:
FEMALE
Phase:
PHASE3
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 d...
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...
Eligibility Criteria
Inclusion
- singleton pregnancy, cephalic presentation, gestation greater than 37 completed weeks, no known contraindication to vaginal delivery, and Bishop score≤5.
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
End Date :
December 1 2004
Estimated Enrollment :
171 Patients enrolled
Trial Details
Trial ID
NCT00299754
Start Date
January 1 2003
End Date
December 1 2004
Last Update
March 7 2006
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National University Hospital
Singapore, Singapore, 119074