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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00247104
Enrollment
200
Registered
2005-11-01
Start date
2007-05-31
Completion date
2008-02-29
Last updated
2007-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fetal Membranes, Premature Rupture, Premature Birth

Keywords

Urinary tract infection, Endometritis, Respiratory Distress Syndrome, Necrotizing enterocolitis, Intraventricular hemorrhage, Latent period, Neonatal infection

Brief summary

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

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.

Interventions

DRUGCranberries - Vaccinium macrocarpon

Sponsors

Hadassah Medical Organization
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Maternal infections (uterus, UTI)
Respiratory distress
Admission to NICU (in days)
Neonatal complications rate (NEC, IVH etc)
Length (in days) of the latent period
Neonatal infection

Secondary

MeasureTime frame
Amniotic fluid pH before and after treatment
Urinary and vaginal flora before and after treatment
Vaginal pH before and after treatment

Countries

Israel

Contacts

Primary ContactShay Porat, MD
shay.porat@gmail.com00 972 2 5844222

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026