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

Further study details as provided by Hadassah Medical Organization:

Primary Outcomes: 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: Urinary and vaginal flora before and after treatment; Vaginal pH before and after treatment; Amniotic fluid pH before and after treatment
Expected Total Enrollment:  200

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 surveillence, 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 pilli-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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Female

Accepts Healthy Volunteers

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00247104

Arik Tzukert, DMD      00 972 2 6776095    arik@hadassah.org.il
Hadas Lemberg, PhD      00 972 2 6777572    lhadas@hadassah.org.il

Israel
      Hadassah Medical Organization, Jerusalem,  Israel

Study chairs or principal investigators

Drorit Hochner-Celnikier, MD,  Study Director,  Hadassah-Hebrew University Medical Center   
Uriel Elchalal, MD,  Study Director,  Hadassah-Hebrew University Medical Center   
Hagit Daum, MD,  Principal Investigator,  Hadassah-Hebrew University Medical Center   
Shay Porat, MD,  Principal Investigator,  Hadassah-Hebrew University Medical Center   

Study ID Numbers:  CRANBERRIES-HMO-CTIL
Last Updated:  December 12, 2005
Record first received:  October 31, 2005
ClinicalTrials.gov Identifier:  NCT00247104
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration
ClinicalTrials.gov processed this record on 2006-01-10