Preinduction cervical ripening with commercially available prostaglandin E2 gel: a randomized, double-blind comparison with a hospital-compounded preparation.
OBJECTIVE
Our purpose was to compare the efficacy, safety, and cost of commercially available dinoprostone cervical gel 0.5 mg with a hospital-compounded formulation.


METHODS
One hundred thirty-four patients undergoing labor induction were randomly assigned to one of two cervical ripening groups. Commercially available dinoprostone gel 0.5 mg or a compounded formulation of 0.5 mg of prostaglandin E2 gel was administered endocervically. On the basis of cervical scores, gel was reapplied at 6-hour intervals for a maximum of three doses. Physicians managing labor were blinded as to treatment group allocation.


RESULTS
Among 134 patients evaluated, 70 were allocated to the commercially available gel and 64 to the compounded gel. No statistically significant differences were noted between the treatment groups with respect to start-to-delivery interval, number of doses, amount of oxytocin, or neonatal adverse outcomes. However, cesarean delivery was performed less frequently in patients in the group receiving the commercially available gel (12.9%) than in the group receiving the compounded gel (28.1%) (p = 0.03). Because of the higher cesarean delivery rate in the compound group, use of this formulation was not associated with cost savings.


CONCLUSIONS
The two prostaglandin E2 formulations appeared equivalent with respect to efficacy. An unexplained higher cesarean section rate, however, was associated with the use of the compounded preparation.
D000293:Adolescent; D000328:Adult; D002584:Cervix Uteri / Q000187:drug effects* / Q000502:physiology; D002585:Cesarean Section / Q000191:economics / Q000706:statistics & numerical data; D016009:Chi-Square Distribution; D015232:Dinoprostone / Q000008:administration & dosage / Q000191:economics / Q000627:therapeutic use*; D004311:Double-Blind Method; D004339:Drug Compounding; D016527:Drug Costs; D005260:Female; D005782:Gels; D017048:Health Care Costs; D006801:Humans; D007751:Labor, Induced; D016015:Logistic Models; D010120:Oxytocics / Q000008:administration & dosage / Q000191:economics / Q000627:therapeutic use*; D010607:Pharmacy Service, Hospital; D011247:Pregnancy
D005782:Gels; D010120:Oxytocics; D015232:Dinoprostone