Cranberry Juice for Preventing Bacteria in Urine During Pregnancy
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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 |
- Number of cases of asymptomatic bacteriuria
- Number of cases of symptomatic urinary tract infection
- Compliance with recommended therapy
- Number of preterm deliveries
| Estimated Enrollment: | 360 |
| Study Start Date: | December 2004 |
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 |
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| 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 | |
| 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:
|
Bacteriuria Urinary Tract Infections Infection Urologic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013