Cranberry Juice for Preventing Bacteria in Urine During Pregnancy - Full Text View

Sponsored by:	National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00093938

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 I

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Cranberry for Prevention of Bacteriuria in Pregnancy

Resource links provided by NLM:

MedlinePlus related topics: Urinary Tract Infections

U.S. FDA Resources

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

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

Locations

United States, California
University of California, Irvine Medical Center
Orange, California, United States, 92868
Women's Pavilion at Miller Children's Hospital (Long Beach Memorial Medical Center)
Long Beach, California, United States, 90806

Sponsors and Collaborators

National Center for Complementary and Alternative Medicine (NCCAM)

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 National Clinical Trials Identifier (NCT ID):

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. Epub 2008 Aug 15.

Study ID Numbers:	DK068527-01
Study First Received:	October 7, 2004
Last Updated:	October 9, 2007
ClinicalTrials.gov Identifier:	NCT00093938 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Vaccinium macrocarpon
Asymptomatic Bacteriuria

Study placed in the following topic categories:

Urologic Diseases
Urinary Tract Infections
Cranberry
Bacteriuria

Additional relevant MeSH terms:

Urologic Diseases
Urinary Tract Infections
Infection
Bacteriuria

ClinicalTrials.gov processed this record on August 13, 2009