Evidence map›Paper›PMID 19515236›Full record

Trial reportBMC infectious diseases2009

Comparison of oral and vaginal metronidazole for treatment of bacterial vaginosis in pregnancy: impact on fastidious bacteria.

Caroline M Mitchell, Jane E Hitti, Kathy J Agnew, David N Fredricks

Registry-linked trialOpen access · goldAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC infectious diseases, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00153517 (Maternal Effects of Bacterial Vaginosis), which is not on this map. Cited by 27 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 2 pooled it
3.7field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00153517 phase2completednot on this map

Maternal Effects of Bacterial Vaginosis (BV) Treatment in Pregnancy (Randomized Trial of BV Treatment in Pregnancy)

TypeinterventionalSponsorCenters for Disease Control and PreventionRan1999 to 2004Enrolled126ConditionsVaginosis, Bacterial, Premature Birth, Birth Weight, ChorioamnionitisArmsoral versus vaginal metronidazole
3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 2 syntheses or guidelines pooled it, 56 citations in OpenAlex.

  1. Antibiotics for treating bacterial vaginosis in pregnancy.The Cochrane database of systematic reviews · 2013
    Pooled it
  2. Antibiotics for treating bacterial vaginosis in pregnancy.The Cochrane database of systematic reviews · 2007
    Pooled it
  3. Trial
  4. Trial
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Review
  12. Critical reviews in microbiology · 2021
    Review
  13. Investigating the efficacy and safety of metronidazole during pregnancy; A systematic review and meta-analysis.European journal of obstetrics & gynecology and reproductive biology: X · 2021
    Review
  14. Review
  15. Article
  16. Anaerobes and bacterial vaginosis in pregnancy: virulence factors contributing to vaginal colonisation.International journal of environmental research and public health · 2014
    Review
  17. Article
  18. Article
  19. Self-collected vaginal swabs for the quantitative real-time polymerase chain reaction assay of Atopobium vaginae and Gardnerella vaginalis and the diagnosis of bacterial vaginosis.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2012
    Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors at 3 institutions in 1 country.

Caroline M MitchellDepartment of Obstetrics & Gynecology, University of Washington, Seattle, WA, USA. camitch@u.washington.edu
Jane E Hitti
Kathy J Agnew
David N Fredricks
Seattle University · USFred Hutch Cancer Center · USUniversity of Washington · US

Funding

WOMEN'S REPRODUCTIVE HEALTH RESEARCH CAREER DEVELOPMENTK12HD001264 · NICHD · UNIVERSITY OF WASHINGTON · PI Barbara Ann Goff · 1998 to 2026
$8.6M
The Role of Uncultivated Bacteria in Bacterial VaginosisR01AI061628 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI FREDRICKS, DAVID NEAL · 2006 to 2016
$6.6M
NIAID NIH HHS R01 AI061628NICHD NIH HHS HD-01-264
6 · The paper itself

Abstract

backgroundBacterial vaginosis (BV) is a common condition that is associated with preterm birth and acquisition of complex communities of vaginal bacteria that include several fastidious species. Treatment of BV in pregnancy has mixed effects on the risk of preterm delivery, which some hypothesize is due to variable antibiotic efficacy for the fastidious bacteria. Both oral and intravaginal metronidazole can be used to treat bacterial vaginosis in pregnancy, but little is known about the impact of different routes of antibiotic administration on concentrations of fastidious vaginal bacteria.

methodsThis was a sub-study of a larger randomized trial of oral versus vaginal metronidazole for treatment of BV in pregnancy. Fifty-three women were evaluated, including 30 women who received oral metronidazole and 23 who received intravaginal metronidazole. Bacterial taxon-specific quantitative PCR assays were used to measure concentrations of bacterial vaginosis associated bacterium (BVAB) 1, 2, and 3, Gardnerella vaginalis, Atopobium species, Leptotrichia/Sneathia species, Megasphaera species, and Lactobacillus crispatus before and after antibiotic treatment.

resultsConcentrations of Leptotrichia and Sneathia spp. and the fastidious Clostridia-like bacterium designated BVAB1 decreased significantly with oral (p = .002, p = .02) but not vaginal therapy (p = .141, p = .126). The fastidious bacterium BVAB3 did not significantly decrease with either treatment. Concentrations of Atopobium spp., reportedly resistant to metronidazole in vitro, dropped significantly with oral (p = .002) and vaginal (p = .001) treatment. There was no significant difference in the magnitude of change in bacterial concentrations between oral and vaginal treatment arms for any of the bacterial species. Lactobacillus crispatus concentrations did not change.

conclusionBoth oral and vaginal metronidazole therapy in pregnant women result in a significant decrease in concentrations of most BV-associated anaerobic bacteria, with the exception that Leptotrichia, Sneathia and BVAB1 do not significantly decrease with vaginal metronidazole therapy. These data suggest that the route of antibiotic administration has a minor impact on bacterial eradication in pregnant women with BV.

trial registrationThis trial is registered with ClinicalTrials.gov, number NCT00153517.

Indexed as

Administration, IntravaginalAdministration, OralAdultAnti-Bacterial AgentsBacteriaFemaleHumansMetronidazolePregnancyPregnancy Complications, InfectiousProspective StudiesTreatment OutcomeVaginaVaginosis, BacterialYoung AdultAnti-Bacterial AgentsMetronidazole

Identifiers

PMID19515236
PMCPMC2703644
OpenAlexW2073807290

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.