From July 2005 through July 2007, a total of 188 women were enrolled in this pilot investigation (). There were no differences in demographic characteristics ().
Participant flow chart for cranberry for the prevention of asymptomatic bacteriuria in pregnancy
There were a total of 27 UTIs in this cohort. There was one case of Enterobacter faecalis cystitis in a woman in Group B, three cases of pyelonephritis due to Escherichia coli (2 in Group A, 1 in Group B), with the remainder of cases attributed to ASB (). Five women had more than one UTI. There was a trend toward fewer UTIs, both asymptomatic and symptomatic, in those women who received multiple daily doses of CJC compared to those women who received placebo. This trend persisted with single daily dosing of CJC, although the magnitude of the difference was less ().
Types of urinary tract infections with uropathogens
Incidence rate ratios for number of cases of asymptomatic bacteriuria and urinary tract infections (Intent-to-treat)
More women in the once daily dosing group and the placebo group were likely to have at least one UTI during the study compared to the multiple daily dosing group (7/67 [10.4%], 7/63 [11.1%] versus 4/58 [6.9%], respectively, p=0.71, Fisher’s exact test). Similar results were seen in evaluating only those UTIs due to enteric bacteria (5/67 [7.5%], 5/63 [7.9%], and 3/58 [5.2%], respectively, p=0.83), and the trend toward reduction in ASB alone for multiple daily cranberry juice cocktail dosing (incidence rate ratio 0.43 [95% CI 0.14–1.39], as well as for single daily cranberry juice cocktail dosing (incidence rate ratio 0.85 [95% CI 0.34–2.08] persisted.
Compliance and tolerability were considerable obstacles during this investigation. Actual dosing regimens, despite the change from thrice to twice daily dosing did not differ between groups with 50.7% (34/67) of Group A,39.7% (23/58) of Group B, and 55.5% (35/63) of Group C consuming placebo juice once or twice daily, p=0.45. Compliance rates differed between groups: 65.7±30.9% in Group A, 78.7±29.2% in Group B, and 76.9±24.9% in Group C of total doses prescribed for duration of participation were consumed, p=0.03. 73/188 (38.8%) subjects could not complete the study and withdrew, most for gastrointestinal upset including nausea, vomiting, diarrhea and dislike of taste (44 of 73). There were fewer withdrawals after the dose change was made (50/136, 36.8%) versus before (23/52, 44.2%, p=0.35).
Evaluating the cohort on an intent-to-treat basis, the median number of days in study was 152.5 [IQR 56–183] for Group A, 158 [IQR 61–181] for Group B, and 171 [IQR 76–185] for Group C, p=0.26. For those who completed the study protocol, the median number of days in study was 183 [IQR 161–195] for Group A (n=41), 177 [IQR 165–185] for Group B (n=31), and 182 [IQR 169–192] for Group C (n=43), p=0.29. For those who withdrew, 56 [IQR 21–77] for Group A (n=27), 56 [IQR 30–90] for Group B (n=26), and 55.5 [IQR 28.5–80] for Group C (n=20), p=0.85.
There were no differences between the groups with regards to obstetrical or neonatal outcomes (). No preterm deliveries less than 34 weeks’ occurred in women with UTIs during this investigation.
Obstetrical and Neonatal Outcomes