Randomized field trial of vaginal douching, XXXX and pregnancy.

@entity1 @entity5851 @entity2953 @entity2348 @entity4134
BACKGROUND: Several case-control studies have reported that @entity1 who use vaginal douche products are at increased risk for @entity4134 . @entity1 who douche regularly may do so for reasons related to their risk of acquiring a @entity2953 , introducing confounding that is difficult to control in non-experimental studies. METHODS: We conducted a multicenter randomized field trial with a 1-year follow-up period. The study comprised 1827 @entity1 age 18-34, with no current indication of @entity4134 , who were regular users of a douche product and who had been treated recently for a sexually transmitted @entity2348 . @entity1 were randomly assigned to use either a newly designed and marketed douche product or a soft cloth towelette, and were resupplied with product at each bimonthly follow-up visit. We measured the occurrence of @entity4134 using a combination of clinical and laboratory indicators. We also recorded pregnancy occurrence among @entity1 . RESULTS: The risk of @entity5851 among @entity1 assigned to use the douche product, relative to that among @entity1 assigned to use the wipe product, was 1.05 (95% confidence interval = 0.57-1.9). Using an alternative, less sensitive definition of @entity5851 gave a risk ratio of 1.26 (0.62-2.6). The probability of becoming pregnant was 15% lower among @entity1 assigned to use a douche product, and 33% lower among @entity1 who douched more frequently (ratio = 0.67; 0.42-1.08). CONCLUSIONS: There was little or no indication of a greater risk of @entity5851 among @entity1 assigned to use the douche product. Douching may be related to a lower probability that a @entity1 becomes pregnant.
