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Cranberry Juice for Preventing Bacteria in Urine During Pregnancy

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ClinicalTrials.gov Identifier: NCT00093938
Recruitment Status : Completed
First Posted : October 8, 2004
Last Update Posted : January 14, 2010
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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).

Condition or disease Intervention/treatment Phase
Urinary Tract Infection Bacteriuria Drug: Cranberry juice Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Cranberry for Prevention of Bacteriuria in Pregnancy
Study Start Date : December 2004

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Number of cases of asymptomatic bacteriuria

Secondary Outcome Measures :
  1. Number of cases of symptomatic urinary tract infection
  2. Compliance with recommended therapy
  3. Number of preterm deliveries

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00093938

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United States, California
Women's Pavilion at Miller Children's Hospital (Long Beach Memorial Medical Center)
Long Beach, California, United States, 90806
University of California, Irvine Medical Center
Orange, California, United States, 92868
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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Principal Investigator: Deborah A. Wing, MD University of California, Irvine Medical Center/Long Beach Memorial Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00093938    
Other Study ID Numbers: DK068527-01 (completed)
First Posted: October 8, 2004    Key Record Dates
Last Update Posted: January 14, 2010
Last Verified: January 2010
Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Vaccinium macrocarpon
Asymptomatic Bacteriuria
Additional relevant MeSH terms:
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Urinary Tract Infections
Urologic Diseases