NCT00247104

Brief Summary

Cranberries have been proved to reduce the rate of urinary tract infections in a population of women with recurrent urinary tract infections in previous studies. The purpose of the study is to examine the efficacy of cranberries in pregnant women with preterm premature rupture of membranes in a)prolonging the latent period (=the time period between the time the water broke and delivery of the fetus) and b)reduction of infectious morbidity of both the mother and infant.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 1, 2005

Completed
1.5 years until next milestone

Study Start

First participant enrolled

May 1, 2007

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

April 11, 2007

Status Verified

March 1, 2006

First QC Date

October 31, 2005

Last Update Submit

April 10, 2007

Conditions

Fetal Membranes, Premature RupturePremature Birth

Keywords

Urinary tract infectionEndometritisRespiratory Distress SyndromeNecrotizing enterocolitisIntraventricular hemorrhageLatent periodNeonatal infection

Outcome Measures

Primary Outcomes (6)

  • Length (in days) of the latent period

  • Neonatal infection

  • Respiratory distress

  • Admission to NICU (in days)

  • Neonatal complications rate (NEC, IVH etc)

  • Maternal infections (uterus, UTI)

Secondary Outcomes (3)

  • Urinary and vaginal flora before and after treatment

  • Vaginal pH before and after treatment

  • Amniotic fluid pH before and after treatment

Interventions

Cranberries - Vaccinium macrocarponDRUG

Eligibility Criteria

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

You may qualify if:

  • Proven premature rupture of membranes
  • less than 35 weeks of gestation with good obstetrical dating
  • no suspicion of amnionitis
  • signed informed consent

You may not qualify if:

  • Known sensitivity / allergy to cranberries
  • Women treated with warfarin
  • Drug intolerance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Israel

Location

Related Publications (3)

  • Jepson RG, Mihaljevic L, Craig J. Cranberries for preventing urinary tract infections. Cochrane Database Syst Rev. 2004;(2):CD001321. doi: 10.1002/14651858.CD001321.pub3.

    PMID: 15106157BACKGROUND

  • 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.

    PMID: 37947276DERIVED

  • 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.

    PMID: 37068952DERIVED

MeSH Terms

Conditions

Fetal Membranes, Premature RupturePremature BirthUrinary Tract InfectionsEndometritisRespiratory Distress SyndromeEnterocolitis, Necrotizing

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesObstetric Labor, PrematureInfectionsUrologic DiseasesFemale Urogenital DiseasesMale Urogenital DiseasesPelvic Inflammatory DiseaseAdnexal DiseasesGenital Diseases, FemaleUterine DiseasesGenital DiseasesLung DiseasesRespiratory Tract DiseasesRespiration DisordersEnterocolitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Drorit Hochner-Celnikier, MD

    Hadassah Medical Organization

    STUDY DIRECTOR

  • Uriel Elchalal, MD

    Hadassah Medical Organization

    STUDY DIRECTOR

  • Hagit Daum, MD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

  • Shay Porat, MD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shay Porat, MD

CONTACT

00 972 2 5844222shay.porat@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 31, 2005

First Posted

November 1, 2005

Study Start

May 1, 2007

Study Completion

February 1, 2008

Last Updated

April 11, 2007

Record last verified: 2006-03

Locations

IL(1)