Induction of Labour Clinical Trial
Official title:
The Randomised-Controlled Trial Of Misoprostol And Dinoprostone Vaginal Pessaries for Cervical Priming (TROMAD Study)
Verified date | June 2005 |
Source | KK Women's and Children's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Singapore: Health Sciences Authority |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 171 |
Est. completion date | December 2004 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | N/A and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Singapore | National University Hospital | Singapore |
Lead Sponsor | Collaborator |
---|---|
KK Women's and Children's Hospital | National Healthcare Group, Singapore |
Singapore,
Rath W. A clinical evaluation of controlled-release dinoprostone for cervical ripening--a review of current evidence in hospital and outpatient settings. J Perinat Med. 2005;33(6):491-9. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary outcome was the number of women who achieved favourable mBS>6 or active labour by Day 2. | |||
Secondary | Secondary outcomes were time interval from insert to active labour or delivery, abnormal uterine activity, delivery method and adverse neonatal outcome. |
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