Improved intravaginal controlled-release prostaglandin E2 insert for cervical ripening at term

Frank R. Witter, Brian M. Mercer

Research output: Contribution to journalArticlepeer-review


The purpose of this study was to determine if prostaglandin E2 (PGE2) in a controlled-release vaginal insert with retrieval system can produce cervical ripening at term. This was a multicenter, double blind, randomized, placebo-controlled study involving 206 patients with 102 receiving active agent. A successful outcome was defined as a change in Bishop score of ≥3, or a Bishop score of ≥6 at 12 h or delivery within 12 h of the insert placement. Analysis was by Fisher's exact test, Wilcoxon's two-sample rank-sum test, and Student's t-test where appropriate. One hundred ninety-three women completed the protocol. Initial Bishop scores were 2.6 ± 1.2 and 2.5 ± 1.4 in the PGE2 and placebo groups, respectively. The incidence of cesarean delivery was identical in the two groups. Uterine hyperstimulation lasted 2-13 min in 5 PGE2 patients (4.9%) with 1 patient requiring tocolysis. More patients in the PGE2 group had a change in Bishop score of ≥3 (62% vs. 40%; P = 0.002), a Bishop score ≥6 after 12 h (46% vs. 34%; P = 0.11), and vaginal delivery within 12 h (6.5% vs. 1%; P = 0.055). Sixty-five percent of PGE2 group patients had a successful outcome vs. 44% of control patients (P = 0.001). In conclusion, when administered in a controlled-release vaginal insert with a retrieval system, PGE2 is effective in promoting cervical ripening at term.

Original languageEnglish (US)
Pages (from-to)64-69
Number of pages6
JournalJournal of Maternal-Fetal and Neonatal Medicine
Issue number2
StatePublished - 1996


  • Cervical ripening
  • Labor induction
  • PGE
  • Pregnancy
  • Prostaglandin

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Obstetrics and Gynecology


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