The Use of Cranberries in Women With Preterm Premature Ru... | NCT00247104

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

NCT00247104

Sponsor

Hadassah Medical Organization

Status

Unknown status

Last Update Posted

Apr 11, 2007Estimated

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Fetal Membranes, Premature Rupture
Premature Birth

Interventions

Cranberries - Vaccinium macrocarpon

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2007

Primary Completion Date

Not provided

Completion Date

Feb 2008Estimated

First Submitted Date

Oct 31, 2005

First Submission Date that Met QC Criteria

Oct 31, 2005

First Posted Date

Nov 1, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 10, 2007

Last Update Posted Date

Apr 11, 2007Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Name	Type	Description	Arm Group Labels	Other Names
Cranberries - Vaccinium macrocarpon	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Urinary and vaginal flora before and after treatment
Vaginal pH before and after treatment
Amniotic fluid pH before and after treatment

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Shay Porat, MD	Contact	00 972 2 5844222		shay.porat@gmail.com

Overall Officials

Name	Affiliation	Role
Drorit Hochner-Celnikier, MD	Hadassah Medical Organization	Study Director
Uriel Elchalal, MD	Hadassah Medical Organization	Study Director
Hagit Daum, MD

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah Medical Organization		Jerusalem			Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15106157	Background	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.
37947276	Derived	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.

ID	Term
D005322	Fetal Membranes, Premature Rupture
D047928	Premature Birth
D014552	Urinary Tract Infections
D004716	Endometritis
D012128	Respiratory Distress Syndrome
D020345	Enterocolitis, Necrotizing

ID	Term
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases