Document Detail

A randomised controlled trial of metronidazole for the prevention of preterm birth in women positive for cervicovaginal fetal fibronectin: the PREMET Study.
MedLine Citation:
PMID:  16398774     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: To determine whether metronidazole reduces early preterm labour in asymptomatic women with positive vaginal fetal fibronectin (fFN) in the second trimester of pregnancy. DESIGN: Randomised placebo-controlled trial. SETTING: Fourteen UK hospitals (three teaching). POPULATION: Pregnancies with at least one previous risk factor, including mid-trimester loss or preterm delivery, uterine abnormality, cervical surgery or cerclage. METHODS: Nine hundred pregnancies were screened for fFN at 24 and 27 weeks of gestation. Positive cases were randomised to a week's course of oral metronidazole or placebo. MAIN OUTCOME MEASURES: Primary outcome was delivery before 30 weeks of gestation. Secondary outcomes included delivery before 37 weeks. RESULTS: The Trial Steering Committee (TSC) recommended the study be stopped early; 21% of women receiving metronidazole (11/53) delivered before 30 weeks compared with 11% (5/46) taking placebo [risk ratio 1.9, 95% confidence interval (CI) 0.72-5.09, P = 0.18]. There were significantly more preterm deliveries (before 37 weeks) in women treated with metronidazole 33/53 (62%) versus placebo 18/46 (39%), risk ratio 1.6, 95% CI 1.05-2.4. fFN was a good predictor of early preterm birth in these asymptomatic women; positive and negative predictive values (24 weeks of gestation) for delivery by 30 weeks were 26% and 99%, respectively (positive and negative likelihood ratios 15, 0.35). CONCLUSION: Metronidazole does not reduce early preterm birth in high risk pregnant women selected by history and a positive vaginal fFN test. Preterm delivery may be increased by metronidazole therapy.
Andrew Shennan; Sarah Crawshaw; Annette Briley; Jenny Hawken; Paul Seed; Griff Jones; Lucilla Poston
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  BJOG : an international journal of obstetrics and gynaecology     Volume:  113     ISSN:  1470-0328     ISO Abbreviation:  BJOG     Publication Date:  2006 Jan 
Date Detail:
Created Date:  2006-01-09     Completed Date:  2006-01-23     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  100935741     Medline TA:  BJOG     Country:  England    
Other Details:
Languages:  eng     Pagination:  65-74     Citation Subset:  AIM; IM    
Maternal and Fetal Research Unit, Division of Reproductive Health, Endocrinology and Development, St Thomas' Hospital, King's College London, UK.
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MeSH Terms
Administration, Oral
Anti-Infective Agents / therapeutic use*
Biological Markers / analysis
Birth Weight
Cervix Uteri / chemistry
Double-Blind Method
Fibronectins / analysis*
Gestational Age
Glycoproteins / analysis*
Metronidazole / therapeutic use*
Obstetric Labor, Premature / prevention & control*
Pregnancy Complications, Infectious / drug therapy*
Pregnancy Outcome
Risk Factors
Tocolytic Agents / therapeutic use*
Vagina / chemistry
Vaginosis, Bacterial / drug therapy*
Reg. No./Substance:
0/Anti-Infective Agents; 0/Biological Markers; 0/FFN protein, human; 0/Fibronectins; 0/Glycoproteins; 0/Tocolytic Agents; 443-48-1/Metronidazole
Comment In:
BJOG. 2006 Jul;113(7):850-1; author reply 851   [PMID:  16827775 ]
BJOG. 2006 Jul;113(7):851-2   [PMID:  16827776 ]
BJOG. 2006 Aug;113(8):976; author reply 976-7   [PMID:  16907946 ]
BJOG. 2006 Jul;113(7):766-8   [PMID:  16827758 ]

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

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