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The Use of Cranberries in Women With Preterm Premature Rupture of Membranes
This study is not yet open for participant recruitment.
Verified by Hadassah Medical Organization, March 2006
First Received: October 31, 2005   Last Updated: April 10, 2007   History of Changes
Sponsored by: Hadassah Medical Organization
Information provided by: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00247104
  Purpose

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 Intervention
Fetal Membranes, Premature Rupture
Premature Birth
Drug: Cranberries - Vaccinium macrocarpon

Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title: The Use of Cranberries in Women With Preterm Premature Rupture of Membranes

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

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

Estimated Enrollment: 200
Study Start Date: May 2007
Estimated Study Completion Date: February 2008
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00247104

Contacts
Contact: Shay Porat, MD 00 972 2 5844222 shay.porat@gmail.com

Locations
Israel
Hadassah Medical Organization
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Study Director: Drorit Hochner-Celnikier, MD Hadassah-Hebrew University Medical Center
Study Director: Uriel Elchalal, MD Hadassah-Hebrew University Medical Center
Principal Investigator: Hagit Daum, MD Hadassah-Hebrew University Medical Center
Principal Investigator: Shay Porat, MD Hadassah-Hebrew University Medical Center
  More Information

Publications:
Study ID Numbers: CRANBERRIES-HMO-CTIL
Study First Received: October 31, 2005
Last Updated: April 10, 2007
ClinicalTrials.gov Identifier: NCT00247104     History of Changes
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:
Urinary tract infection
Endometritis
Respiratory Distress Syndrome
Necrotizing enterocolitis
Intraventricular hemorrhage
Latent period
Neonatal infection

Study placed in the following topic categories:
Endometritis
Pregnancy Complications
Obstetric Labor, Premature
Urinary Tract Infections
Necrotizing Enterocolitis
Obstetric Labor Complications
Wounds and Injuries
Rupture
Disorders of Environmental Origin
Fetal Membranes, Premature Rupture
Hemorrhage
Enterocolitis
Cranberry
Enterocolitis, Necrotizing
Premature Birth

Additional relevant MeSH terms:
Pregnancy Complications
Obstetric Labor, Premature
Wounds and Injuries
Obstetric Labor Complications
Disorders of Environmental Origin
Rupture
Fetal Membranes, Premature Rupture
Premature Birth

ClinicalTrials.gov processed this record on September 10, 2009