Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2025-12-25 @ 7:08 PM
Study NCT ID:
NCT00247104
Status:
UNKNOWN
Last Update Posted:
2007-04-11
First Post:
2005-10-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Use of Cranberries in Women With Preterm Premature Rupture of Membranes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005322', 'term': 'Fetal Membranes, Premature Rupture'}, {'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D014552', 'term': 'Urinary Tract Infections'}, {'id': 'D004716', 'term': 'Endometritis'}, {'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D020345', 'term': 'Enterocolitis, Necrotizing'}], 'ancestors': [{'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D000292', 'term': 'Pelvic Inflammatory Disease'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D004760', 'term': 'Enterocolitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-03', 'completionDateStruct': {'date': '2008-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2007-04-10', 'studyFirstSubmitDate': '2005-10-31', 'studyFirstSubmitQcDate': '2005-10-31', 'lastUpdatePostDateStruct': {'date': '2007-04-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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)'}], 'secondaryOutcomes': [{'measure': 'Urinary and vaginal flora before and after treatment'}, {'measure': 'Vaginal pH before and after treatment'}, {'measure': 'Amniotic fluid pH before and after treatment'}]}, 'conditionsModule': {'keywords': ['Urinary tract infection', 'Endometritis', 'Respiratory Distress Syndrome', 'Necrotizing enterocolitis', 'Intraventricular hemorrhage', 'Latent period', 'Neonatal infection'], 'conditions': ['Fetal Membranes, Premature Rupture', 'Premature Birth']}, 'referencesModule': {'references': [{'pmid': '15106157', 'type': 'BACKGROUND', '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.'}, {'pmid': '37947276', 'type': 'DERIVED', 'citation': 'Williams G, Stothart CI, Hahn D, Stephens JH, Craig JC, Hodson EM. Cranberries for preventing urinary tract infections. Cochrane Database Syst Rev. 2023 Nov 10;11(11):CD001321. doi: 10.1002/14651858.CD001321.pub7.'}, {'pmid': '37068952', 'type': 'DERIVED', 'citation': 'Williams G, Hahn D, Stephens JH, Craig JC, Hodson EM. Cranberries for preventing urinary tract infections. Cochrane Database Syst Rev. 2023 Apr 17;4(4):CD001321. doi: 10.1002/14651858.CD001321.pub6.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nCranberries 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.\n\nWe 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Proven premature rupture of membranes\n* less than 35 weeks of gestation with good obstetrical dating\n* no suspicion of amnionitis\n* signed informed consent\n\nExclusion Criteria:\n\n* Known sensitivity / allergy to cranberries\n* Women treated with warfarin\n* Drug intolerance'}, 'identificationModule': {'nctId': 'NCT00247104', 'briefTitle': 'The Use of Cranberries in Women With Preterm Premature Rupture of Membranes', 'organization': {'class': 'OTHER', 'fullName': 'Hadassah Medical Organization'}, 'officialTitle': 'The Use of Cranberries in Women With Preterm Premature Rupture of Membranes', 'orgStudyIdInfo': {'id': 'CRANBERRIES-HMO-CTIL'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Cranberries - Vaccinium macrocarpon', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jerusalem', 'country': 'Israel', 'contacts': [{'name': 'Arik Tzukert, DMD', 'role': 'CONTACT', 'email': 'arik@hadassah.org.il', 'phone': '00 972 2 6776095'}, {'name': 'Hadas Lemberg, PhD', 'role': 'CONTACT', 'email': 'lhadas@hadassah.org.il', 'phone': '00 972 2 6777572'}], 'facility': 'Hadassah Medical Organization', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'centralContacts': [{'name': 'Shay Porat, MD', 'role': 'CONTACT', 'email': 'shay.porat@gmail.com', 'phone': '00 972 2 5844222'}], 'overallOfficials': [{'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', 'affiliation': 'Hadassah Medical Organization'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hadassah Medical Organization', 'class': 'OTHER'}}}}