NCT00093938

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).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 8, 2004

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2004

Completed
Last Updated

January 14, 2010

Status Verified

January 1, 2010

First QC Date

October 7, 2004

Last Update Submit

January 12, 2010

Conditions

Keywords

Vaccinium macrocarponAsymptomatic Bacteriuria

Outcome Measures

Primary Outcomes (1)

  • Number of cases of asymptomatic bacteriuria

Secondary Outcomes (3)

  • Number of cases of symptomatic urinary tract infection

  • Compliance with recommended therapy

  • Number of preterm deliveries

Interventions

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Intrauterine pregnancy
  • Mother and fetus in good health
  • Mother pregnant for 16 weeks or less

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Women's Pavilion at Miller Children's Hospital (Long Beach Memorial Medical Center)

Long Beach, California, 90806, United States

Location

University of California, Irvine Medical Center

Orange, California, 92868, United States

Location

Related Publications (4)

  • Williams G, Stothart CI, Hahn D, Stephens JH, Craig JC, Hodson EM. Cranberries for preventing urinary tract infections. Cochrane Database Syst Rev. 2023 Nov 10;11(11):CD001321. doi: 10.1002/14651858.CD001321.pub7.

  • Williams G, Hahn D, Stephens JH, Craig JC, Hodson EM. Cranberries for preventing urinary tract infections. Cochrane Database Syst Rev. 2023 Apr 17;4(4):CD001321. doi: 10.1002/14651858.CD001321.pub6.

  • Wing DA, Rumney PJ, Leu SY, Zaldivar F. Comparison of urinary cytokines after ingestion of cranberry juice cocktail in pregnant subjects: a pilot study. Am J Perinatol. 2010 Feb;27(2):137-42. doi: 10.1055/s-0029-1224867. Epub 2009 Jun 26.

  • 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. doi: 10.1016/j.juro.2008.06.016. Epub 2008 Aug 15.

MeSH Terms

Conditions

Urinary Tract InfectionsBacteriuria

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Deborah A. Wing, MD

    University of California, Irvine Medical Center/Long Beach Memorial Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

October 7, 2004

First Posted

October 8, 2004

Study Start

December 1, 2004

Last Updated

January 14, 2010

Record last verified: 2010-01

Locations