Document Detail

Outcome of the Vaginal Infections and Prematurity Study: results of a clinical trial of erythromycin among pregnant women colonized with group B streptococci.
MedLine Citation:
PMID:  7755068     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: Our purpose was to determine whether erythromycin treatment of pregnant women colonized with group B streptococci would reduce the occurrence of low birth weight (< 2500 gm) and preterm (< 37 completed weeks) birth. STUDY DESIGN: In a double-blind clinical trial, 938 carriers of group B streptococci were randomized to receive erythromycin base (333 mg three times a day) or matching placebo beginning during the third trimester and before 30 weeks and continuing for 10 weeks or until 35 weeks 6 days of pregnancy. RESULTS: Pregnancy outcomes were available for 97% of randomized women; 14% of subjects withdrew from the trial. Birth weight < 2500 gm occurred in 8.6% of the erythromycin and 6.1% of the placebo recipients (relative risk 1.4, 0.9 to 2.2, p = 0.16). Preterm delivery occurred in 11.4% of women randomized to erythromycin and in 12.3% randomized to placebo (relative risk 0.9, 95% confidence limits 0.6 to 1.3, p = 0.65). Greater benefit of erythromycin in reducing these outcomes was not observed among women reporting the best compliance. CONCLUSIONS: In this study of pregnant women colonized with group B streptococci treatment with erythromycin was not shown to be effective at prolonging gestation or reducing low birth weight. Greater than anticipated complicating factors, including spontaneous clearance of the organism, use of nontrial antibiotics, and density of colonization, may have resulted in population sizes too small to detect a benefit of treatment. Future studies should take these factors into account in determining sample sizes.
M A Klebanoff; J A Regan; A V Rao; R P Nugent; W C Blackwelder; D A Eschenbach; J G Pastorek; S Williams; R S Gibbs; J C Carey
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, U.S. Gov't, P.H.S.    
Journal Detail:
Title:  American journal of obstetrics and gynecology     Volume:  172     ISSN:  0002-9378     ISO Abbreviation:  Am. J. Obstet. Gynecol.     Publication Date:  1995 May 
Date Detail:
Created Date:  1995-06-19     Completed Date:  1995-06-19     Revised Date:  2007-11-14    
Medline Journal Info:
Nlm Unique ID:  0370476     Medline TA:  Am J Obstet Gynecol     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  1540-5     Citation Subset:  AIM; IM    
National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD 20892, USA.
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MeSH Terms
Birth Weight
Double-Blind Method
Erythromycin / therapeutic use*
Infant, Low Birth Weight
Infant, Newborn
Infant, Premature*
Obstetric Labor, Premature / prevention & control*
Pregnancy Complications, Infectious / drug therapy*,  microbiology
Pregnancy Outcome*
Streptococcal Infections / drug therapy*,  microbiology
Streptococcus agalactiae* / isolation & purification
United States
Vagina / microbiology*
Vaginosis, Bacterial / drug therapy*,  microbiology
Grant Support
Reg. No./Substance:

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

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