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 da
tabase of randomized trials, on-line searching of MEDLINE, hand searching o
f bibliographies, and contact with authors of relevant reports.
Methods of Study Selection: Randomized trials were included if they compare
d 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 h
ours postinsertion, uterine hypertonus with fetal heart change, and cesarea
n delivery rate. Study inclusion, validity assessment, and data extraction
were carried out independently by two reviewers, and cross-checked for cons
istency. Data were combined when appropriate, using the Mantel-Haenszel fix
ed-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 ge
l and two with misoprostol. Five trials reported adequate methods for rando
mization 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 hyperto
nus 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), respecti
vely. The secondary end points of mean time to delivery and delivery by 12
hours appeared to favor misoprostol-dinoprostone gel. However, data for the
se end points were heterogeneous and their combination is therefore of limi
ted value and potentially misleading.
Conclusion: No clinically significant differences were identified between t
he vaginal insert and alternatives used for cervical ripening at term. (C)
2001 by The American College of Obstetricians and Gynecologists.