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A Pilot Study of Vaginal Flora Changes With Randomization to Cessation of Douching

Klebanoff, Mark A. MD, MPH*; Andrews, William W. PhD, MD; Yu, Kai Fun PhD*; Brotman, Rebecca M. MPH*; Nansel, Tonja R. PhD*; Zhang, Jun MD, PhD*; Cliver, Suzanne P. MA; Schwebke, Jane R. MD

doi: 10.1097/01.olq.0000216050.41305.c1

Objectives: The objectives of this study were to determine whether women who douche regularly would enter a randomized trial of douching cessation or continuation, whether they would adhere to the assigned behavior, and whether there was a dramatic impact on vaginal flora.

Goal: The goal of this study was to determine the feasibility of a large, definitive trial of douching cessation.

Study Design: Women who douched at least weekly and who had either bacterial vaginosis or normal flora by Gram stain were assigned at random either to continue douching or to stop for 8 weeks. Vaginal Gram stains were obtained every 7 days from each woman.

Results: Forty-eight women were randomized. Those assigned to continue reported douching during 77% of study weeks; those assigned to stop denied douching in 94% of weeks. No dramatic differences in flora were observed between women in the continue versus stop groups.

Conclusion: A large randomized trial of douching cessation is feasible.

A pilot study of randomization of 48 women who douche regularly to stop or continue douching demonstrated adequate compliance with no dramatic changes in vaginal flora.

From the * National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland; and the † University of Alabama at Birmingham, Birmingham, Alabama

Supported by Contract NO-1-HD-8-3293 and by Intramural funds from the National Institute of Child Health and Human Development.

Correspondence: Mark A. Klebanoff, MD, MPH, DESPR, NICHD, NIH, 6100 Bldg., Room 7B05, Bethesda, MD 20892. E-mail:

Received for publication September 8, 2005, and accepted January 31, 2006.

© Copyright 2006 American Sexually Transmitted Diseases Association