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Cranberry Juice for Preventing Bacteria in Urine During Pregnancy

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00093938
First received: October 7, 2004
Last updated: January 12, 2010
Last verified: January 2010

October 7, 2004
January 12, 2010
December 2004
Not Provided
Number of cases of asymptomatic bacteriuria
Same as current
Complete list of historical versions of study NCT00093938 on ClinicalTrials.gov Archive Site
  • Number of cases of symptomatic urinary tract infection
  • Compliance with recommended therapy
  • Number of preterm deliveries
Same as current
Not Provided
Not Provided
 
Cranberry Juice for Preventing Bacteria in Urine During Pregnancy
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).

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
  • Urinary Tract Infection
  • Bacteriuria
Drug: Cranberry juice
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
360
Not Provided
Not Provided

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
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00093938
DK068527-01 (completed)
Not Provided
Not Provided
National Center for Complementary and Alternative Medicine (NCCAM)
Not Provided
Principal Investigator: Deborah A. Wing, MD University of California, Irvine Medical Center/Long Beach Memorial Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP