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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00247104
Recruitment Status : Unknown
Verified March 2006 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : November 1, 2005
Last Update Posted : April 11, 2007
Information provided by:
Hadassah Medical Organization

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.

Condition or disease Intervention/treatment Phase
Fetal Membranes, Premature Rupture Premature Birth Drug: Cranberries - Vaccinium macrocarpon Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: The Use of Cranberries in Women With Preterm Premature Rupture of Membranes
Study Start Date : May 2007
Estimated Study Completion Date : February 2008

Primary Outcome Measures :
  1. Length (in days) of the latent period
  2. Neonatal infection
  3. Respiratory distress
  4. Admission to NICU (in days)
  5. Neonatal complications rate (NEC, IVH etc)
  6. Maternal infections (uterus, UTI)

Secondary Outcome Measures :
  1. Urinary and vaginal flora before and after treatment
  2. Vaginal pH before and after treatment
  3. Amniotic fluid pH before and after treatment

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00247104

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Contact: Shay Porat, MD 00 972 2 5844222

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Hadassah Medical Organization
Jerusalem, Israel
Contact: Arik Tzukert, DMD    00 972 2 6776095   
Contact: Hadas Lemberg, PhD    00 972 2 6777572   
Sponsors and Collaborators
Hadassah Medical Organization
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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
Layout table for additonal information Identifier: NCT00247104    
First Posted: November 1, 2005    Key Record Dates
Last Update Posted: April 11, 2007
Last Verified: March 2006
Keywords provided by Hadassah Medical Organization:
Urinary tract infection
Respiratory Distress Syndrome
Necrotizing enterocolitis
Intraventricular hemorrhage
Latent period
Neonatal infection
Additional relevant MeSH terms:
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Premature Birth
Fetal Membranes, Premature Rupture
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Wounds and Injuries