Trial Of Misoprostol And Dinoprostone Vaginal Pessaries for Cervical Priming (TROMAD Study)
Information source: KK Women's and Children's Hospital
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Induction of Labour
Intervention: Misoprostol (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: KK Women's and Children's Hospital Official(s) and/or principal investigator(s):
Thiam-Chye Tan, Principal Investigator, Affiliation: KK Women's and Children's Hospital
Tseng-Meng Chua, Principal Investigator, Affiliation: National University Hospital, Singapore
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.
Clinical Details
Official title: The Randomised-Controlled Trial Of Misoprostol And Dinoprostone Vaginal Pessaries for Cervical Priming (TROMAD Study)
Study design: Treatment, Randomized, Single Blind, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Primary outcome: The primary outcome was the number of women who achieved favourable mBS>6 or active labour by Day 2.
Secondary outcome: Secondary outcomes were time interval from insert to active labour or delivery, abnormal uterine activity, delivery method and adverse neonatal outcome.
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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- singleton pregnancy, cephalic presentation, gestation greater than 37 completed weeks,
no known contraindication to vaginal delivery, and Bishop scoreâ¤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.
Locations and Contacts
National University Hospital, Singapore 119074, Singapore
Additional Information
Starting date: January 2003
Ending date: December 2004
Last updated: March 6, 2006
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