- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00093938
Cranberry Juice for Preventing Bacteria in Urine During Pregnancy
Cranberry for Prevention of Bacteriuria in Pregnancy
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
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California
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Long Beach, California, United States, 90806
- Women's Pavilion at Miller Children's Hospital (Long Beach Memorial Medical Center)
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Orange, California, United States, 92868
- University of California, Irvine Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Number of cases of asymptomatic bacteriuria
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Secondary Outcome Measures
Outcome Measure |
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Number of cases of symptomatic urinary tract infection
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Compliance with recommended therapy
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Number of preterm deliveries
|
Collaborators and Investigators
Investigators
- Principal Investigator: Deborah A. Wing, MD, University of California, Irvine Medical Center/Long Beach Memorial Medical Center
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DK068527-01 (completed)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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