Clinical trial NCT00093938: Cranberry Juice for Preventing Bacteria in Urine During Pregnancy
Official title: Cranberry for Prevention of Bacteriuria in Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Urinary Tract Infection
Bacteriuria
Keywords: Vaccinium macrocarpon
Asymptomatic Bacteriuria
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2004-10-08
Enrollment: 360
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine the amount of cranberry juice that is most effective in preventing a condition in pregnant women that often leads to urinary tract infections (UTIs).

Detailed description: Asymptomatic bacteriuria (ASB) infection, a condition in which a large number of bacteria are present in the urine, often precedes the development of symptomatic UTIs. UTIs are common among women and may create complications during pregnancy. By incorporating cranberry juice into their diets, pregnant women may be able to lower their risk for UTIs caused by ASB, and cranberry juice may also prevent preterm labor and birth. This study will determine the cranberry juice-containing regimen that will work best for preventing ASB in pregnant women.

For the duration of their pregnancy, participants in this study will be randomly assigned to one of three treatment arms: cranberry juice once a day, cranberry juice three times a day, or a placebo beverage three times a day. The level of bacteria in their urine will be measured at monthly study visits. Women who test positive for a UTI will receive oral antibiotic therapy. All women will be monitored throughout their pregnancies for UTIs and other related complications.

Eligibility criteria: Inclusion Criteria:

* Intrauterine pregnancy
* Mother and fetus in good health
* Mother pregnant for 16 weeks or less

Exclusion Criteria:

* Suspected nonviable or ectopic pregnancy
* Mother plans to terminate pregnancy
* Antimicrobial therapy, for reasons other than urinary tract infections, within 2 weeks prior to study start
* Significant underlying medical complications that may interfere with the study

Primary outcomes:
measure: Number of cases of asymptomatic bacteriuria
Secondary outcomes:
measure: Number of cases of symptomatic urinary tract infection
measure: Compliance with recommended therapy
measure: Number of preterm deliveries
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Women's Pavilion at Miller Children's Hospital (Long Beach Memorial Medical Center)
state: California
city: Orange
country: United States
facility: University of California, Irvine Medical Center
state: California
Study officials:
affiliation: University of California, Irvine Medical Center/Long Beach Memorial Medical Center
name: Deborah A. Wing, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wing DA, Rumney PJ, Leu SY, Zaldivar F. Comparison of urinary cytokines after ingestion of cranberry juice cocktail in pregnant subjects: a pilot study. Am J Perinatol. 2010 Feb;27(2):137-42. doi: 10.1055/s-0029-1224867. Epub 2009 Jun 26.
citation: Wing DA, Rumney PJ, Preslicka CW, Chung JH. Daily cranberry juice for the prevention of asymptomatic bacteriuria in pregnancy: a randomized, controlled pilot study. J Urol. 2008 Oct;180(4):1367-72. doi: 10.1016/j.juro.2008.06.016. Epub 2008 Aug 15.