The Use of Cranberries in Women With Preterm Premature Rupture of Membranes
Primary Purpose
Fetal Membranes, Premature Rupture, Premature Birth
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Cranberries - Vaccinium macrocarpon
Sponsored by
About this trial
This is an interventional prevention trial for Fetal Membranes, Premature Rupture focused on measuring Urinary tract infection, Endometritis, Respiratory Distress Syndrome, Necrotizing enterocolitis, Intraventricular hemorrhage, Latent period, Neonatal infection
Eligibility Criteria
Inclusion Criteria: Proven premature rupture of membranes less than 35 weeks of gestation with good obstetrical dating no suspicion of amnionitis signed informed consent Exclusion Criteria: Known sensitivity / allergy to cranberries Women treated with warfarin Drug intolerance
Sites / Locations
- Hadassah Medical Organization
Outcomes
Primary Outcome Measures
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 Outcome Measures
Urinary and vaginal flora before and after treatment
Vaginal pH before and after treatment
Amniotic fluid pH before and after treatment
Full Information
NCT ID
NCT00247104
First Posted
October 31, 2005
Last Updated
April 10, 2007
Sponsor
Hadassah Medical Organization
1. Study Identification
Unique Protocol Identification Number
NCT00247104
Brief Title
The Use of Cranberries in Women With Preterm Premature Rupture of Membranes
Official Title
The Use of Cranberries in Women With Preterm Premature Rupture of Membranes
Study Type
Interventional
2. Study Status
Record Verification Date
March 2006
Overall Recruitment Status
Unknown status
Study Start Date
May 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Hadassah Medical Organization
4. Oversight
5. Study Description
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.
Detailed Description
Preterm premature rupture of membranes (PPROM) complicates 2-3.5% of pregnancies and precipitates labor in 30-40% of preterm deliveries. The common practice in early PPROM with no evidence of chorioamnionitis is admission for close surveillance, antibiotic treatment and steroids for fetal lung maturation (until 32 weeks gestation. Intraamniotic infection is evident in up to 75% of women who develop labor during admission. The infection is for the most an ascending infection.
Cranberries have been recognized by the American Indians as a natural means for preventing urinary tract infection. The mechanism of action includes acidification of urine and inhibition of adhesion of pili-harboring bacteria to the transitional epithelium of the urinary tract.
We assume that cranberries will lower the rate of maternal urinary tract infection. Moreover, the active ingredients will pass transplacentally to the fetus, will be secreted in its urine hence, in the amniotic fluid. The active substances would coat the vagina and bring about their effect also in that environment. Having in mind that most if not all chorioamnionitis infections are caused by ascending infection, the cranberries might lengthen the latent period and reduce infectious maternal and neonatal morbidity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal Membranes, Premature Rupture, Premature Birth
Keywords
Urinary tract infection, Endometritis, Respiratory Distress Syndrome, Necrotizing enterocolitis, Intraventricular hemorrhage, Latent period, Neonatal infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Cranberries - Vaccinium macrocarpon
Primary Outcome Measure Information:
Title
Length (in days) of the latent period
Title
Neonatal infection
Title
Respiratory distress
Title
Admission to NICU (in days)
Title
Neonatal complications rate (NEC, IVH etc)
Title
Maternal infections (uterus, UTI)
Secondary Outcome Measure Information:
Title
Urinary and vaginal flora before and after treatment
Title
Vaginal pH before and after treatment
Title
Amniotic fluid pH before and after treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Proven premature rupture of membranes
less than 35 weeks of gestation with good obstetrical dating
no suspicion of amnionitis
signed informed consent
Exclusion Criteria:
Known sensitivity / allergy to cranberries
Women treated with warfarin
Drug intolerance
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shay Porat, MD
Phone
00 972 2 5844222
Email
shay.porat@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Drorit Hochner-Celnikier, MD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Uriel Elchalal, MD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hagit Daum, MD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shay Porat, MD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Medical Organization
City
Jerusalem
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arik Tzukert, DMD
Phone
00 972 2 6776095
Email
arik@hadassah.org.il
First Name & Middle Initial & Last Name & Degree
Hadas Lemberg, PhD
Phone
00 972 2 6777572
Email
lhadas@hadassah.org.il
12. IPD Sharing Statement
Citations:
PubMed Identifier
15106157
Citation
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.
Results Reference
background
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The Use of Cranberries in Women With Preterm Premature Rupture of Membranes
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