Document Detail


The "PRIM" study: a randomized comparison of prostaglandin E2 gel with the nitric oxide donor isosorbide mononitrate for cervical ripening before the induction of labor at term.
MedLine Citation:
PMID:  16580290     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: The purpose of this study was to compare the efficacy and safety profile of prostaglandin E2 with isosorbide mononitrate for cervical ripening before the induction of labor at term. STUDY DESIGN: Primigravid women were assigned randomly to receive either 40 mg of isosorbide mononitrate or 2 mg of prostaglandin E2. Efficacy outcomes were the cervical ripening effect of each agent and the time from treatment initiation to delivery. Safety outcomes were the incidence and frequency of maternal side effects and events that would be potentially hazardous for mother and baby during outpatient cervical ripening. RESULTS: Prostaglandin E2 was more effective than isosorbide mononitrate in inducing a change in modified Bishop score. Mean duration from treatment initiation to delivery was greater for isosorbide mononitrate than prostaglandin E2. There were no adverse events in the isosorbide mononitrate group that would contraindicate outpatient treatment. However, in the prostaglandin E2 group, 7% of the pregnancies had abnormal fetal heart rate patterns (P = .0002). Maternal satisfaction was significantly higher in the isosorbide mononitrate group. CONCLUSION: Although isosorbide mononitrate was less effective, maternal satisfaction was significantly greater. The safety profile of each agent was such that it would be reasonable to give isosorbide mononitrate, but not prostaglandin E2, on an outpatient basis.
Authors:
Inass Osman; Fiona MacKenzie; John Norrie; Heather M Murray; Ian A Greer; Jane E Norman
Publication Detail:
Type:  Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  American journal of obstetrics and gynecology     Volume:  194     ISSN:  1097-6868     ISO Abbreviation:  Am. J. Obstet. Gynecol.     Publication Date:  2006 Apr 
Date Detail:
Created Date:  2006-04-03     Completed Date:  2006-05-18     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  0370476     Medline TA:  Am J Obstet Gynecol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1012-21     Citation Subset:  AIM; IM    
Affiliation:
Division of Developmental Medicine, University of Glasgow, Glasgow Royal Infirmary, United Kingdom.
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MeSH Terms
Descriptor/Qualifier:
Adult
Cervical Ripening / drug effects*
Dinoprostone*
Double-Blind Method
Female
Gels
Humans
Isosorbide Dinitrate / analogs & derivatives*,  therapeutic use
Labor, Induced*
Nitric Oxide Donors / therapeutic use*
Oxytocics*
Pregnancy
Chemical
Reg. No./Substance:
0/Gels; 0/Nitric Oxide Donors; 0/Oxytocics; 16051-77-7/isosorbide-5-mononitrate; 363-24-6/Dinoprostone; 87-33-2/Isosorbide Dinitrate

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


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