Cranberry for Prevention of Bacteriuria in Pregnancy
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).
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.
Status: Completed (Phase 1). Started on December 1st, 2004.
Enrollment: 360 subjects
Study Type: Interventional
Study Design:
- Allocation: Randomized
- Endpoint Classification: Efficacy Study
- Intervention Model: Parallel Assignment
- Masking: Double-Blind
- Primary Purpose: Prevention
Conditions:
Interventions:
- Drug: Cranberry juice
Eligibility
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
- Gender
Female
- Mininum Age
18 Years
- Maximum Age
N/A
- Healthy Volunteers
Accepts Healthy Volunteers
Resources
Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Authority: United States: Federal Government
Locations
-
Women's Pavilion at Miller Children's Hospital (Long Beach Memorial Medical Center)
Long Beach
California
90806
United States
-
University of California, Irvine Medical Center
Orange
California
92868
United States
Officials
Deborah A. Wing, MD (Principal Investigator, University of California, Irvine Medical Center/Long Beach Memorial Medical Center)
Sponsors
National Center for Complementary and Alternative Medicine (NCCAM) (Lead Sponsor)
References
None.
Links
None.
- Date Verified
- January 1st, 2010
- First Received
- January 12th, 2010
- Last Changed
- January 12th, 2010
Information obtained from ClinicalTrials.gov on June 09, 2011. Link to the current ClinicalTrials.gov record.
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