Objective: To compare dinoprostone 10 mg controlled-release vaginal insert with other forms of vaginal or cervical prostaglandin for cervical ripening.
Data Sources: Literature search strategy included review of the Cochrane database of randomized trials, on-line searching of MEDLINE, hand searching of bibliographies, and contact with authors of relevant reports.
Methods of Study Selection: Randomized trials were included if they compared a dinoprostone slow-release vaginal insert with an alternative vaginal or cervical prostaglandin for cervical ripening and labor induction in women at term with singleton gestations. Primary end points were delivery by 24 hours postinsertion, uterine hypertonus with fetal heart change, and cesarean delivery rate. Study inclusion, validity assessment, and data extraction were carried out independently by two reviewers, and cross-checked for consistency. Data were combined when appropriate, using the Mantel–Haenszel fixed-effects method. Statistical heterogeneity was assessed using chi-square statistics.
Tabulation, Integration, and Results: Nine relevant trials were identified, seven comparing the dinoprostone 10 mg vaginal insert with dinoprostone gel and two with misoprostol. Five trials reported adequate methods for randomization concealment. None were double blind. The likelihood of delivery by 24 hours was similar with the vaginal insert and alternatives: common odds ratio (OR) 0.80 (95% confidence interval [CI] 0.56, 1.15). Uterine hypertonus with change in fetal heart and cesarean delivery rate were also similar: common OR 1.19 (95% CI 0.56, 2.54) and 0.78 (95% CI 0.56, 1.08), respectively. The secondary end points of mean time to delivery and delivery by 12 hours appeared to favor misoprostol-dinoprostone gel. However, data for these end points were heterogeneous and their combination is therefore of limited value and potentially misleading.
Conclusion: No clinically significant differences were identified between the vaginal insert and alternatives used for cervical ripening at term.
Dinoprostone vaginal insert and other vaginal or cervical prostaglandins are similarly effective for cervical ripening at term.
Department of Obstetrics & Gynecology, McMaster University, Hamilton, Ontario, Canada; and Clinical Effectiveness Support Unit, Royal College of Obstetrics and Gynecology, London, UK.
Address reprint requests to: Edward G. Hughes, MB, ChB, FRCSC, Department of Obstetrics & Gynecology, McMaster University Medical Centre, 1200 Main Street West, Room 4D14, Hamilton, Ontario L8N 3Z5, Canada. E-mail: firstname.lastname@example.org
Received June 7, 2000. Received in revised form October 27, 2000. Accepted December 12, 2000.