Cranberry Juice for Preventing Bacteria in Urine During Pregnancy
Primary Purpose
Urinary Tract Infection, Bacteriuria
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cranberry juice
Sponsored by
About this trial
This is an interventional prevention trial for Urinary Tract Infection focused on measuring Vaccinium macrocarpon, Asymptomatic Bacteriuria
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
Sites / Locations
- Women's Pavilion at Miller Children's Hospital (Long Beach Memorial Medical Center)
- University of California, Irvine Medical Center
Outcomes
Primary Outcome Measures
Number of cases of asymptomatic bacteriuria
Secondary Outcome Measures
Number of cases of symptomatic urinary tract infection
Compliance with recommended therapy
Number of preterm deliveries
Full Information
NCT ID
NCT00093938
First Posted
October 7, 2004
Last Updated
January 12, 2010
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT00093938
Brief Title
Cranberry Juice for Preventing Bacteria in Urine During Pregnancy
Official Title
Cranberry for Prevention of Bacteriuria in Pregnancy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infection, Bacteriuria
Keywords
Vaccinium macrocarpon, Asymptomatic Bacteriuria
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
360 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Cranberry juice
Primary Outcome Measure Information:
Title
Number of cases of asymptomatic bacteriuria
Secondary Outcome Measure Information:
Title
Number of cases of symptomatic urinary tract infection
Title
Compliance with recommended therapy
Title
Number of preterm deliveries
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah A. Wing, MD
Organizational Affiliation
University of California, Irvine Medical Center/Long Beach Memorial Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Women's Pavilion at Miller Children's Hospital (Long Beach Memorial Medical Center)
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
University of California, Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19562652
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.
Results Reference
derived
PubMed Identifier
18707726
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.
Results Reference
derived
Learn more about this trial
Cranberry Juice for Preventing Bacteria in Urine During Pregnancy
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