The Use of Cranberries in Women With Preterm Premature Rupture of Membranes
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|ClinicalTrials.gov Identifier: NCT00247104|
Recruitment Status : Unknown
Verified March 2006 by Hadassah Medical Organization.
Recruitment status was: Not yet recruiting
First Posted : November 1, 2005
Last Update Posted : April 11, 2007
|Condition or disease||Intervention/treatment||Phase|
|Fetal Membranes, Premature Rupture Premature Birth||Drug: Cranberries - Vaccinium macrocarpon||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||The Use of Cranberries in Women With Preterm Premature Rupture of Membranes|
|Study Start Date :||May 2007|
|Estimated Study Completion Date :||February 2008|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00247104
|Contact: Shay Porat, MD||00 972 2 email@example.com|
|Hadassah Medical Organization||Not yet recruiting|
|Contact: Arik Tzukert, DMD 00 972 2 6776095 firstname.lastname@example.org|
|Contact: Hadas Lemberg, PhD 00 972 2 6777572 email@example.com|
|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|