Cranberry Juice for Preventing Bacteria in Urine During Pregnancy

• Sponsor: National Center for Complementary and Integrative Health (NCCIH) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT00093938
• Collaborator: (none)
• Enrollment: 360
• Locations: 2
• Patients Per Site: 180

Study Details

Study Description

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.

Study Design

• Study Type: Interventional
• Anticipated 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: Dec 1, 2004

Outcome Measures

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 []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Women's Pavilion at Miller Children's Hospital (Long Beach Memorial Medical Center)	Long Beach	California	United States	90806
2	University of California, Irvine Medical Center	Orange	California	United States	92868

Sponsors and Collaborators

• National Center for Complementary and Integrative Health (NCCIH)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00093938
• Other Study ID Numbers: DK068527-01 (completed)
• First Posted: Oct 8, 2004
• Last Update Posted: Jan 14, 2010
• Last Verified: Jan 1, 2010

• Keywords provided by , ,: Vaccinium macrocarpon; Asymptomatic Bacteriuria
• Additional relevant MeSH terms: Urinary Tract Infections; Bacteriuria

Study Results

No Results Posted as of Jan 14, 2010