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Sponsors and Collaborators: |
KK Women's and Children's Hospital National Healthcare Group, Singapore |
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Information provided by: | KK Women's and Children's Hospital |
ClinicalTrials.gov Identifier: | NCT00299754 |
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.
Condition | Intervention | Phase |
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Induction of Labour |
Drug: Misoprostol |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
Official Title: | The Randomised-Controlled Trial Of Misoprostol And Dinoprostone Vaginal Pessaries for Cervical Priming (TROMAD Study) |
Estimated Enrollment: | 171 |
Study Start Date: | January 2003 |
Estimated Study Completion Date: | December 2004 |
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.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Singapore | |
National University Hospital | |
Singapore, Singapore, 119074 |
Principal Investigator: | Thiam-Chye Tan | KK Women's and Children's Hospital |
Principal Investigator: | Tseng-Meng Chua | National University Hospital, Singapore |
Study ID Numbers: | TCTan001 |
Study First Received: | March 6, 2006 |
Last Updated: | March 6, 2006 |
ClinicalTrials.gov Identifier: | NCT00299754 |
Health Authority: | Singapore: Health Sciences Authority |
Low dose misoprostol dinoprostone cervical priming |
Dinoprostone Misoprostol |
Oxytocics Therapeutic Uses Anti-Ulcer Agents Abortifacient Agents Physiological Effects of Drugs |
Gastrointestinal Agents Reproductive Control Agents Abortifacient Agents, Nonsteroidal Pharmacologic Actions |