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| Tracking Information | |||||||||
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| First Received Date ICMJE | March 6, 2006 | ||||||||
| Last Updated Date | March 6, 2006 | ||||||||
| Start Date ICMJE | January 2003 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE |
The primary outcome was the number of women who achieved favourable mBS>6 or active labour by Day 2. | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
Secondary outcomes were time interval from insert to active labour or delivery, abnormal uterine activity, delivery method and adverse neonatal outcome. | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Trial Of Misoprostol And Dinoprostone Vaginal Pessaries for Cervical Priming (TROMAD Study) | ||||||||
| Official Title ICMJE | The Randomised-Controlled Trial Of Misoprostol And Dinoprostone Vaginal Pessaries for Cervical Priming (TROMAD Study) | ||||||||
| 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. |
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| 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. |
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| Study Phase | Phase III | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Randomized, Single Blind, Dose Comparison, Single Group Assignment, Safety/Efficacy Study | ||||||||
| Condition ICMJE | Induction of Labour | ||||||||
| Intervention ICMJE | Drug: Misoprostol | ||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | 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. | ||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 171 | ||||||||
| Completion Date | December 2004 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | |||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Singapore | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00299754 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | TCTan001 | ||||||||
| Study Sponsor ICMJE | KK Women's and Children's Hospital | ||||||||
| Collaborators ICMJE | National Healthcare Group, Singapore | ||||||||
| Investigators ICMJE |
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| Information Provided By | KK Women's and Children's Hospital | ||||||||
| Verification Date | June 2005 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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