- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00247104
The Use of Cranberries in Women With Preterm Premature Rupture of Membranes
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Shay Porat, MD
- Phone Number: 00 972 2 5844222
- Email: shay.porat@gmail.com
Study Locations
-
-
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Jerusalem, Israel
- Hadassah Medical Organization
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Length (in days) of the latent period
|
Neonatal infection
|
Respiratory distress
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Admission to NICU (in days)
|
Neonatal complications rate (NEC, IVH etc)
|
Maternal infections (uterus, UTI)
|
Secondary Outcome Measures
Outcome Measure |
---|
Urinary and vaginal flora before and after treatment
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Vaginal pH before and after treatment
|
Amniotic fluid pH before and after treatment
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Drorit Hochner-Celnikier, MD, Hadassah Medical Organization
- Study Director: Uriel Elchalal, MD, Hadassah Medical Organization
- Principal Investigator: Hagit Daum, MD, Hadassah Medical Organization
- Principal Investigator: Shay Porat, MD, Hadassah Medical Organization
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRANBERRIES-HMO-CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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