Document Detail

An intravaginal controlled-release prostaglandin E2 pessary for cervical ripening and initiation of labor at term.
MedLine Citation:
PMID:  1738517     Owner:  NLM     Status:  MEDLINE    
The purpose of this randomized, double-blind study was to evaluate the efficacy and safety of a new controlled-release hydrogel pessary for ripening the cervix and initiating labor. Subjects had an entry Bishop score of 4 or less and gestational age of 37 or more weeks. One hundred fourteen women received a placebo pessary and 101 received the hydrogel pessary, containing 10 mg of prostaglandin (PG) E2. Compared with the placebo group, those given the PGE2 pessary were more likely to have an increase in Bishop score of 3 or more (60 or 59% versus 21 or 18%; P less than .0001), change to a Bishop score of 6 or higher (59 or 58% versus 18 or 16%; P less than .0001), and active labor (68 or 67% versus 15 or 13%; P less than .0001). Including the crossover study, uterine hyperstimulation (28 of 182, 15%) and fetal heart rate abnormalities (18 of 182, 10%) in PGE2-treated subjects were reversed on removal of the pessary with no apparent harm to the mother or fetus. These temporary adverse effects appeared while the pessary was in place and after the onset of active labor. Oxytocin was unnecessary in 89 of 182 (49%) of the PGE2-treated cases and was used more often to augment than to induce labor. We conclude that the described controlled-release PGE2 vaginal pessary induces appreciable cervical ripening and frequently initiates active labor with little or no need for oxytocin. The pessary may cause uterine hyperstimulation or fetal heart rate abnormalities, but these would be expected to reverse on removal of the pessary.
W F Rayburn; R J Wapner; V A Barss; E Spitzberg; R D Molina; N Mandsager; M L Yonekura
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Obstetrics and gynecology     Volume:  79     ISSN:  0029-7844     ISO Abbreviation:  Obstet Gynecol     Publication Date:  1992 Mar 
Date Detail:
Created Date:  1992-03-18     Completed Date:  1992-03-18     Revised Date:  2009-10-26    
Medline Journal Info:
Nlm Unique ID:  0401101     Medline TA:  Obstet Gynecol     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  374-9     Citation Subset:  AIM; IM    
Department of Obstetrics and Gynecology, University of Nebraska Medical Center, Omaha.
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MeSH Terms
Delayed-Action Preparations
Dinoprostone / administration & dosage*,  adverse effects
Double-Blind Method
Labor, Induced*
Reg. No./Substance:
0/Delayed-Action Preparations; 363-24-6/Dinoprostone

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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