Preinduction cervical ripening with commercially available prostaglandin E2 gel

A randomized, double-blind comparison with a hospital-compound preparation

Luis Sanchez-Ramos, Lisa A. Farah, Andrew M. Kaunitz, Charles Adair, Gerardo O. Del Valle, Paula Fuqua

Research output: Contribution to journalArticle

10 Citations (Scopus)

Abstract

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. STUDY DESIGN: 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 compounded 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.

Original languageEnglish (US)
Pages (from-to)1079-1084
Number of pages6
JournalAmerican Journal of Obstetrics and Gynecology
Volume173
Issue number4
DOIs
StatePublished - Jan 1 1995

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Cervical Ripening
Dinoprostone
Gels
Induced Labor
Cost Savings
Oxytocin
Cesarean Section
Physicians
Safety
Costs and Cost Analysis

All Science Journal Classification (ASJC) codes

  • Obstetrics and Gynecology

Cite this

Preinduction cervical ripening with commercially available prostaglandin E2 gel : A randomized, double-blind comparison with a hospital-compound preparation. / Sanchez-Ramos, Luis; Farah, Lisa A.; Kaunitz, Andrew M.; Adair, Charles; Del Valle, Gerardo O.; Fuqua, Paula.

In: American Journal of Obstetrics and Gynecology, Vol. 173, No. 4, 01.01.1995, p. 1079-1084.

Research output: Contribution to journalArticle

Sanchez-Ramos, Luis ; Farah, Lisa A. ; Kaunitz, Andrew M. ; Adair, Charles ; Del Valle, Gerardo O. ; Fuqua, Paula. / Preinduction cervical ripening with commercially available prostaglandin E2 gel : A randomized, double-blind comparison with a hospital-compound preparation. In: American Journal of Obstetrics and Gynecology. 1995 ; Vol. 173, No. 4. pp. 1079-1084.
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