Diaphragm Used with Replens Gel and Risk of Bacterial Vaginosis: Results from a Randomized Controlled Trial
Table 2
The odds of prevalent bacterial vaginosis (BV) during followup in participants randomized to intervention compared to control arms, stratified by presence and absence of BV, normal vaginal flora, and normal lactobacillus at enrollment.
Vaginal gram stain findings at enrollment
BV present
BV absent
Normal vaginal flora*
Normal
Intent-to-treat analysis (OR, 95% CI)
1.01 (0.52–1.94)
1.21 (0.65–2.27)
1.37 (0.62–3.07)
1.06 (0.63–1.79)
Per-protocol analysis (reported diaphragm used at last sex) (OR, 95% CI)
0.90 (0.46–1.76)
1.34 (0.68–2.62)
1.64 (0.71–3.82)
0.96 (0.56–1.65)
Per-protocol analysis (reported diaphragm always used since last visit‡) (OR, 95% CI)
1.17 (0.56–2.45)
1.83 (0.90–3.71)
2.52 (1.04–6.12)
1.23 (0.70–2.20)
*Nugent’s score = 0–3. †Lactobacillus score = 0-1 per Nugent’s score. ‡Generally three months.
