Clinical trial NCT00247104: The Use of Cranberries in Women With Preterm Premature Rupture of Membranes
Official title: The Use of Cranberries in Women With Preterm Premature Rupture of Membranes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fetal Membranes, Premature Rupture
Premature Birth
Keywords: Urinary tract infection
Endometritis
Respiratory Distress Syndrome
Necrotizing enterocolitis
Intraventricular hemorrhage
Latent period
Neonatal infection
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2005-11-01
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Length (in days) of the latent period
measure: Neonatal infection
measure: Respiratory distress
measure: Admission to NICU (in days)
measure: Neonatal complications rate (NEC, IVH etc)
measure: Maternal infections (uterus, UTI)
Secondary outcomes:
measure: Urinary and vaginal flora before and after treatment
measure: Vaginal pH before and after treatment
measure: Amniotic fluid pH before and after treatment
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Drorit Hochner-Celnikier, MD
role: STUDY_DIRECTOR
affiliation: Hadassah Medical Organization
name: Uriel Elchalal, MD
role: STUDY_DIRECTOR
affiliation: Hadassah Medical Organization
name: Hagit Daum, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hadassah Medical Organization
name: Shay Porat, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jepson RG, Mihaljevic L, Craig J. Cranberries for preventing urinary tract infections. Cochrane Database Syst Rev. 2004;(2):CD001321. doi: 10.1002/14651858.CD001321.pub3.