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Sponsored by: |
Hadassah Medical Organization |
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Information provided by: | Hadassah Medical Organization |
ClinicalTrials.gov Identifier: | NCT00247104 |
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 |
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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 |
Estimated Enrollment: | 200 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | February 2008 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Shay Porat, MD | 00 972 2 5844222 | shay.porat@gmail.com |
Israel | |
Hadassah Medical Organization | |
Jerusalem, Israel |
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 |
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 |
Urinary tract infection Endometritis Respiratory Distress Syndrome Necrotizing enterocolitis |
Intraventricular hemorrhage Latent period Neonatal infection |
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 |
Pregnancy Complications Obstetric Labor, Premature Wounds and Injuries Obstetric Labor Complications |
Disorders of Environmental Origin Rupture Fetal Membranes, Premature Rupture Premature Birth |