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Cranberry Juice for Preventing Bacteria in Urine During Pregnancy - Article


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Cranberry

American Cranberry; Arandano; Mossberry; Vaccinium macrocarpon; Vaccinium species


Clinical Trial: Cranberry Juice for Preventing Bacteria in Urine During Pregnancy

This study is not yet open for patient recruitment.

Sponsored by: National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Purpose

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 Treatment or Intervention Phase
Urinary Tract Infection
Bacteriuria
 Drug: Cranberry juice
Phase I

MedlinePlus related topics:  Urinary Tract Infections

Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Official Title: Cranberry for Prevention of Bacteriuria in Pregnancy

Further Study Details: 
Primary Outcomes: Number of cases of asymptomatic bacteriuria
Secondary Outcomes: Number of cases of symptomatic urinary tract infection; Compliance with recommended therapy; Number of preterm deliveries
Expected Total Enrollment:  360

Study start: December 2004

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.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Female

Accepts Healthy Volunteers

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

Location Information

Pamela J. Rumney, RNC      714-456-2217    prumney@uci.edu
Deborah A. Wing, MD      714-456-5967    dwing@uci.edu

California
      University of California, Irvine Medical Center, Orange,  California,  92868,  United States
Pamela J. Rumney, RNC  714-456-2217    prumney@uci.edu 
Deborah A. Wing, MD  714-456-5967    dwing@uci.edu 
Deborah A. Wing, MD,  Principal Investigator

Study chairs or principal investigators

Deborah A. Wing, MD,  Principal Investigator,  University of California, Irvine Medical Center/Long Beach Memorial Medical Center   

More Information

Study ID Numbers:  DK068527-01
Record last reviewed:  November 2004
Last Updated:  November 17, 2004
Record first received:  October 7, 2004
ClinicalTrials.gov Identifier:  NCT00093938
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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