A randomized trial of preinduction cervical ripening: dinoprostone vaginal insert versus double-balloon catheter.
OBJECTIVE
We sought to compare the efficacy of a double-balloon transcervical catheter to that of a prostaglandin (PG) vaginal insert among women undergoing labor induction.


METHODS
In all, 210 women with a Bishop score ≤6 were assigned randomly to cervical ripening with either a double-balloon device or a PGE2 sustained-release vaginal insert. Primary outcome was vaginal delivery within 24 hours.


RESULTS
The proportion of women who achieved vaginal delivery in 24 hours was higher in the double-balloon group than in the PGE2 group (68.6% vs 49.5%; odds ratio, 2.22; 95% confidence interval, 1.26-3.91). There was no difference in cesarean delivery rates (23.8% vs 26.2%; odds ratio, 0.88; 95% confidence interval, 0.47-1.65). Oxytocin and epidural analgesia were administered more frequently when a double-balloon device was used. Uterine tachysystole or hypertonus occurred more frequently in the PGE2 arm (9.7% vs 0%, P = .0007).


CONCLUSIONS
The use of a double-balloon catheter for cervical ripening is associated with a higher rate of vaginal birth within 24 hours compared with a PGE2 vaginal insert.
Department of Obstetrics and Gynecology, University of Insubria, Varese, Italy. antonellacromi@libero.it
Antonella
A
Cromi
Fabio
F
Ghezzi
Stefano
S
Uccella
Massimo
M
Agosti
Maurizio
M
Serati
Giulia
G
Marchitelli
Pierfrancesco
P
Bolis
D000282:Administration, Intravaginal; D000328:Adult; D015360:Analgesia, Epidural / Q000706:statistics & numerical data; D002404:Catheterization; D020070:Cervical Ripening; D002585:Cesarean Section / Q000706:statistics & numerical data; D036861:Delivery, Obstetric / Q000706:statistics & numerical data; D015232:Dinoprostone / Q000627:therapeutic use*; D004363:Drug Utilization / Q000706:statistics & numerical data; D005260:Female; D006801:Humans; D007751:Labor, Induced / Q000295:instrumentation / Q000379:methods*; D007902:Length of Stay / Q000706:statistics & numerical data; D008875:Middle Aged; D009122:Muscle Hypertonia / Q000209:etiology; D010120:Oxytocics / Q000627:therapeutic use*; D010121:Oxytocin / Q000627:therapeutic use; D006473:Postpartum Hemorrhage / Q000453:epidemiology; D011247:Pregnancy; D013997:Time Factors; D014590:Uterine Contraction; D055815:Young Adult
D010120:Oxytocics; D010121:Oxytocin; D015232:Dinoprostone