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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Fetal Membranes, Premature Rupture, Premature Birth

Intervention / Treatment
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* Drug: Cranberries - Vaccinium macrocarpon


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Cranberries - Vaccinium macrocarpon|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary and vaginal flora before and after treatment |  |  | 
| Vaginal pH before and after treatment |  |  | 
| Amniotic fluid pH before and after treatment |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urinary tract infection, Endometritis, Respiratory Distress Syndrome, Necrotizing enterocolitis, Intraventricular hemorrhage, Latent period, Neonatal infection