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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2006 by Hadassah Medical Organization.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00247104
First received: October 31, 2005
Last updated: April 10, 2007
Last verified: March 2006
History of Changes

October 31, 2005
April 10, 2007
May 2007
Not Provided
  • 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)
Same as current
Complete list of historical versions of study NCT00247104 on ClinicalTrials.gov Archive Site
  • Urinary and vaginal flora before and after treatment
  • Vaginal pH before and after treatment
  • Amniotic fluid pH before and after treatment
Same as current
Not Provided
Not Provided
 
The Use of Cranberries in Women With Preterm Premature Rupture of Membranes
The Use of Cranberries in Women With Preterm Premature Rupture of Membranes

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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
  • Fetal Membranes, Premature Rupture
  • Premature Birth
Drug: Cranberries - Vaccinium macrocarpon
Not Provided
Jepson RG, Mihaljevic L, Craig J. Cranberries for preventing urinary tract infections. Cochrane Database Syst Rev. 2004;(2):CD001321. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
200
February 2008
Not Provided

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
Female
18 Years and older
Yes
Contact: Shay Porat, MD 00 972 2 5844222 shay.porat@gmail.com
Israel
 
NCT00247104
CRANBERRIES-HMO-CTIL
Not Provided
Not Provided
Hadassah Medical Organization
Not Provided
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
Hadassah Medical Organization
March 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP