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
  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 Intervention Phase
Urinary Tract Infection
Bacteriuria
Drug: Cranberry juice
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Cranberry for Prevention of Bacteriuria in Pregnancy

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

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

Estimated Enrollment: 360
Study Start Date: December 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00093938

Locations
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
Investigators
Principal Investigator: Deborah A. Wing, MD University of California, Irvine Medical Center/Long Beach Memorial Medical Center
  More Information

No publications provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00093938     History of Changes
Other Study ID Numbers: DK068527-01 (completed)
Study First Received: October 7, 2004
Last Updated: January 12, 2010
Health Authority: United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Vaccinium macrocarpon
Asymptomatic Bacteriuria

Additional relevant MeSH terms:
Urinary Tract Infections
Bacteriuria
Infection
Urologic Diseases

ClinicalTrials.gov processed this record on September 16, 2014