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QUESTION: In women having Papanicolaou (Pap) smears, does the application of water soluble gel lubricant to the plastic vaginal speculum change the rate of unsatisfactory cervical cytology diagnosis?
Design
Cluster randomised {allocation concealed*}†, blinded (outcome assessors),* controlled trial.
Setting
5 public health family planning clinics in Seattle, Washington, USA.
Patients
2906 women of reproductive age (mean age 23 y) undergoing cervical cytology specimen collection. All patients were included in the analysis.
Intervention
Patients were allocated to water soluble gel lubricant (water, propylene glycol, hydroxpropyl methylcellulose, carbomer 934P, methylparaben, propylparaben, and sodium hydroxide) (n=1440) or no lubricant except tap water (n=1466) for all speculum examinations for cervical cytology specimen collection.
Main outcome measures
The main outcome measure was unsatisfactory cytology diagnoses. Other cervical cytology results included atypical squamous cells of undetermined significance [ASCUS], low grade squamous …
Footnotes
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Source of funding: National Institutes of Health.
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For correspondence: Dr A M Amies, University of Washington Medical Center, Seattle, WA, USA.aamies{at}u.washington.edu
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† Information provided by author.