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The Use of Cranberries in Women With Preterm Premature Rupture of Membranes

NCT ID: NCT00247104

Last Updated: 2007-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2008-02-29

Brief Summary

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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

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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.

Conditions

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Fetal Membranes, Premature Rupture Premature Birth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Cranberries - Vaccinium macrocarpon

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Principal Investigators

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Drorit Hochner-Celnikier, MD

Role: STUDY_DIRECTOR

Hadassah Medical Organization

Uriel Elchalal, MD

Role: STUDY_DIRECTOR

Hadassah Medical Organization

Hagit Daum, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Shay Porat, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Locations

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Hadassah Medical Organization

Jerusalem, , Israel

Site Status

Countries

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Israel

Central Contacts

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Shay Porat, MD

Role: CONTACT

[email protected]
00 972 2 5844222

Facility Contacts

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Arik Tzukert, DMD

Role: primary

[email protected]
00 972 2 6776095

Hadas Lemberg, PhD

Role: backup

[email protected]
00 972 2 6777572

References

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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.

Reference Type BACKGROUND
PMID: 15106157 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37947276 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37068952 (View on PubMed)

Other Identifiers

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CRANBERRIES-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id