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.
The goal of this study was to determine the feasibility of a large, definitive trial of douching cessation.
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.
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.
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: firstname.lastname@example.org
Received for publication September 8, 2005, and accepted January 31, 2006.