Document Detail

A prospective randomized safety trial of celecoxib for treatment of preterm labor.
MedLine Citation:
PMID:  12237643     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: We compared the safety of celecoxib, a selective cyclo-oxygenase-2 inhibitor, with the safety of the nonselective cyclo-oxygenase inhibitor indomethacin, when it was administered for treatment of preterm labor. STUDY DESIGN: In a randomized, double-blind, placebo-controlled trial, 24 pregnant women in preterm labor at 24 to 34 weeks of gestation received either indomethacin or celecoxib for 48 hours. Clinical assessment, fetal sonography, and Doppler blood flow studies of the fetal ductus arteriosus were performed daily. RESULTS: Mean maximum ductal flow velocity was significantly elevated over baseline (82.9 +/- 4.6 cm/s vs 111.14 +/- 14.3 cm/s; P =.02) after 24 hours of indomethacin, but not celecoxib. Both medications were associated with a transient decrease in amniotic fluid volume, with a greater effect by indomethacin. The medications were equally effective in the maintenance of tocolysis. There were no significant maternal or neonatal adverse events. CONCLUSION: In this initial evaluation, the safety of short-term celecoxib in women with preterm labor was superior to that of indomethacin.
Catherine S Stika; Gilad A Gross; Gustavo Leguizamon; Susan Gerber; Roni Levy; Amit Mathur; Lisa M Bernhard; D Michael Nelson; Yoel Sadovsky
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  American journal of obstetrics and gynecology     Volume:  187     ISSN:  0002-9378     ISO Abbreviation:  Am. J. Obstet. Gynecol.     Publication Date:  2002 Sep 
Date Detail:
Created Date:  2002-09-18     Completed Date:  2002-10-18     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:  653-60     Citation Subset:  AIM; IM    
Department of Obstetrics and Gynecology, Northwestern University, Chicago, Ill., USA.
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MeSH Terms
Cyclooxygenase Inhibitors / therapeutic use*
Double-Blind Method
Indomethacin / adverse effects
Obstetric Labor, Premature / drug therapy*
Prospective Studies
Sulfonamides / adverse effects*
Tocolytic Agents / adverse effects*
Reg. No./Substance:
0/Cyclooxygenase Inhibitors; 0/Pyrazoles; 0/Sulfonamides; 0/Tocolytic Agents; 169590-42-5/celecoxib; 53-86-1/Indomethacin

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

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