The Use of Cranberries in Women With Preterm Premature Rupture of Membranes
Recruitment status was Not yet recruiting
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.
Fetal Membranes, Premature Rupture
Drug: Cranberries - Vaccinium macrocarpon
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Official Title:||The Use of Cranberries in Women With Preterm Premature Rupture of Membranes|
- 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)
- Urinary and vaginal flora before and after treatment
- Vaginal pH before and after treatment
- Amniotic fluid pH before and after treatment
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00247104
|Contact: Shay Porat, MD||00 972 2 firstname.lastname@example.org|
|Hadassah Medical Organization||Not yet recruiting|
|Contact: Arik Tzukert, DMD 00 972 2 6776095 email@example.com|
|Contact: Hadas Lemberg, PhD 00 972 2 6777572 firstname.lastname@example.org|
|Study Director:||Drorit Hochner-Celnikier, MD||Hadassah Medical Organization|
|Study Director:||Uriel Elchalal, MD||Hadassah Medical Organization|
|Principal Investigator:||Hagit Daum, MD||Hadassah Medical Organization|
|Principal Investigator:||Shay Porat, MD||Hadassah Medical Organization|