Clinical Study

Diaphragm Used with Replens Gel and Risk of Bacterial Vaginosis: Results from a Randomized Controlled Trial

Table 1

Baseline demographics, clinical and exam findings, and initial laboratory findings for trial participants by group assignment.

Baseline characteristicsIntervention ( )Control ( )

Sociodemographic variables
 Age (mean ± SD)28.1 (7.4)28.1 (6.9)
 Married249 (95%)251 (95%)
 Years of education (mean ± SD)9.6 (2.1)9.9 (1.9)
 How many live births
  Number of live births (mean ± SD)2.3 (1.6)2.3 (1.6)
 Current contraceptive method (multiple methods reported)
  Long term (i.e., tubal ligation)4 (2%)3 (1%)
  Injectable hormones (i.e., depomedroxyprogesterone)36 (14%)42 (16%)
  Combined oral contraceptives160 (61%)171 (65%)
  Barrier (i.e., condom)36 (14%)33 (12%)
  Other/none27 (10%)16 (6%)
 Number of sexual partners in life (median, range)1 (1–10)1 (1–5)
 Number of times sex in last 3 months (mean ± SD)4.4 (3.3)4.5 (3.5)
 Reported condom use at last sex 190 (72%)200 (75%)
 Reported condom use in past 3 months
  Never79 (30%)70 (26%)
  Sometimes114 (43%)113 (43%)
  Always69 (26%)82 (31%)
Clinical history and exam at enrollment
 History of abnormal discharge during past 3 months 8 (3%)6 (2%)
 History of abnormal discharge ongoing 1 (0.4%)0 (0%)
 Abnormal vaginal discharge on exam 18 (7%)22 (8%)
Screening laboratory results
 BV diagnosed by Gram stain criteria
  Normal (Nugent’s score: 0–3)120 (46%)120 (45%)
  Intermediate (Nugent’s score: 4–6) 41 (16%)34 (13%)
  BV (Nugent’s score: 7–10)102 (39%)111 (42%)
Lactobacillus by Gram stain (median, range)2 (0–4)2 (0–4)
Lactobacillus Gram stain score abnormal (2–4)144 (55%)139 (52%)
 Vaginal pH ≥ 4.7 109 (43%)109 (43%)
Chlamydia trachomatis 4 (1.5%)3 (1.1%)
Neisseria gonorrhoeae 3 (1.1%)1 (0.4%)
Trichomonas vaginalis 8 (3.0%)7 (2.6%)
 HSV-2 seropositive 128 (48.7%)128 (48.3%)