Cranberry Juice for Preventing Bacteria in Urine During Pregnancy

Urinary Tract Infection Clinical Trial

Official title:

Cranberry for Prevention of Bacteriuria in Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00093938
• Other study ID #: DK068527-01 (completed)
• Status: Completed
• Phase: Phase 1
• First received: October 7, 2004
• Last updated: January 12, 2010
• Start date: December 2004

Study information

• Verified date: January 2010
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bacteriuria
• Urinary Tract Infection
• Urinary Tract Infections

Intervention

Drug:
• Cranberry juice

Locations

Country	Name	City	State
United States	Women's Pavilion at Miller Children's Hospital (Long Beach Memorial Medical Center)	Long Beach	California
United States	University of California, Irvine Medical Center	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of cases of asymptomatic bacteriuria
Secondary	Number of cases of symptomatic urinary tract infection
Secondary	Compliance with recommended therapy
Secondary	Number of preterm deliveries