Abstract
Objectives: 1) To compare a self-collected vaginal swab FemExam test card result to Nugent Gram stain scoring of the same specimen, and 2) To test the hypothesis that treatment of bacterial vaginosis (BV) begun on the day of an elective abortion will reduce postabortion endometritis in the women treated. Methods: Women seeking first- or second-trimester abortion, testing +/+ on the pH and amine test card (FemExam), defined as positive for BV, were randomized to metronidazole 1gm before the procedure and 500 mg twice a day for 7 days or identical placebo capsules. Results: Between April 1999 and June 2000, 2,355 women were approached. Of the 1,764 women tested, 683 (39%) tested BV positive by FemExam, and 399 (58%) enrolled in the randomized trial. In a subset of 212 FemExam-negative women, not one had a 10 or 9 Gram stain vaginal flora score, but 18 women had scores of 7 or 8. Conversely, 90/321 (28%) BV- positive FemExam subjects had 0–3 or negative Gram stain scores for BV (sensitivity 94.6%, specificity 67.4%). Because the study is still blinded for analysis, we do not know whether the women with endometritis were placebo- or metronidazole-assigned subjects. The study power will detect the difference between a 12.2% and a 3.8% endometritis rate. Conclusions: The FemExam card does not require a pelvic exam. It allows quick diagnosis (but possibly overdiagnosis) of BV before abortion. Final data analysis will show whether there is treatment benefit.
Published Version
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