Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2026-03-01 @ 3:54 PM
Study NCT ID:
NCT03213535
Status:
UNKNOWN
Last Update Posted:
2017-07-12
First Post:
2017-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Urea and Creatinine Level in Vaginal Fluid as a Predicator for Length of Latency Period in Prelabour Membranes Rupture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005322', 'term': 'Fetal Membranes, Premature Rupture'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'targetDuration': '2 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2017-07-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-07-10', 'studyFirstSubmitDate': '2017-07-08', 'studyFirstSubmitQcDate': '2017-07-08', 'lastUpdatePostDateStruct': {'date': '2017-07-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'delivery interval in Premature rupture of membranes', 'timeFrame': '48 hours', 'description': 'The time needed from the onset of PROM till time of onset of labour'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PROM'], 'conditions': ['Rupture of Membranes; Premature']}, 'referencesModule': {'references': [{'pmid': '16437525', 'type': 'BACKGROUND', 'citation': 'Dare MR, Middleton P, Crowther CA, Flenady VJ, Varatharaju B. Planned early birth versus expectant management (waiting) for prelabour rupture of membranes at term (37 weeks or more). Cochrane Database Syst Rev. 2006 Jan 25;(1):CD005302. doi: 10.1002/14651858.CD005302.pub2.'}, {'pmid': '27160546', 'type': 'BACKGROUND', 'citation': 'Gezer C, Ekin A, Golbasi C, Kocahakimoglu C, Bozkurt U, Dogan A, Solmaz U, Golbasi H, Taner CE. Use of urea and creatinine levels in vaginal fluid for the diagnosis of preterm premature rupture of membranes and delivery interval after membrane rupture. J Matern Fetal Neonatal Med. 2017 Apr;30(7):772-778. doi: 10.1080/14767058.2016.1188072. Epub 2016 May 26.'}, {'pmid': '16967274', 'type': 'BACKGROUND', 'citation': 'Kafali H, Oksuzler C. Vaginal fluid urea and creatinine in diagnosis of premature rupture of membranes. Arch Gynecol Obstet. 2007 Mar;275(3):157-60. doi: 10.1007/s00404-006-0240-1. Epub 2006 Sep 12.'}, {'pmid': '16026409', 'type': 'BACKGROUND', 'citation': 'Kim YH, Park YW, Kwon HS, Kwon JY, Kim BJ. Vaginal fluid beta-human chorionic gonadotropin level in the diagnosis of premature rupture of membranes. Acta Obstet Gynecol Scand. 2005 Aug;84(8):802-5. doi: 10.1111/j.0001-6349.2005.00712.x.'}, {'pmid': '19900043', 'type': 'BACKGROUND', 'citation': 'Melamed N, Hadar E, Ben-Haroush A, Kaplan B, Yogev Y. Factors affecting the duration of the latency period in preterm premature rupture of membranes. J Matern Fetal Neonatal Med. 2009 Nov;22(11):1051-6. doi: 10.3109/14767050903019650.'}, {'pmid': '14746949', 'type': 'BACKGROUND', 'citation': 'Ngwenya S, Lindow SW. 24 hour rhythm in the timing of pre-labour spontaneous rupture of membranes at term. Eur J Obstet Gynecol Reprod Biol. 2004 Feb 10;112(2):151-3. doi: 10.1016/s0301-2115(03)00286-0.'}, {'pmid': '11847525', 'type': 'BACKGROUND', 'citation': 'Oliveira FR, Barros EG, Magalhaes JA. Biochemical profile of amniotic fluid for the assessment of fetal and renal development. Braz J Med Biol Res. 2002 Feb;35(2):215-22. doi: 10.1590/s0100-879x2002000200010.'}, {'pmid': '15846196', 'type': 'BACKGROUND', 'citation': 'Ramsey PS, Lieman JM, Brumfield CG, Carlo W. Chorioamnionitis increases neonatal morbidity in pregnancies complicated by preterm premature rupture of membranes. Am J Obstet Gynecol. 2005 Apr;192(4):1162-6. doi: 10.1016/j.ajog.2004.11.035.'}, {'pmid': '24259235', 'type': 'BACKGROUND', 'citation': 'Pintucci A, Meregalli V, Colombo P, Fiorilli A. Premature rupture of membranes at term in low risk women: how long should we wait in the "latent phase"? J Perinat Med. 2014 Mar;42(2):189-96. doi: 10.1515/jpm-2013-0017.'}, {'pmid': '15507990', 'type': 'BACKGROUND', 'citation': 'Ramsey PS, Nuthalapaty FS, Lu G, Ramin S, Nuthalapaty ES, Ramin KD. Contemporary management of preterm premature rupture of membranes (PPROM): a survey of maternal-fetal medicine providers. Am J Obstet Gynecol. 2004 Oct;191(4):1497-502. doi: 10.1016/j.ajog.2004.08.005.'}, {'type': 'BACKGROUND', 'citation': 'Tigga M.P. and Malik S. Comparative analysis of four biomarkers in diagnosing premature rupture of membranes and their correlation with onset of labour: Int J Reprod Contracept Obstet Gynecol. 2015 Aug;4(4):1070-1075'}, {'pmid': '6654186', 'type': 'BACKGROUND', 'citation': 'Tyden O, Eriksson U, Agren H, Berne C. Estimation of fetal maturity by amniotic fluid cytology, creatinine, lecithin/sphingomyelin ratio and phosphatidylglycerol. Gynecol Obstet Invest. 1983;16(6):317-26. doi: 10.1159/000299289.'}, {'pmid': '22545024', 'type': 'BACKGROUND', 'citation': 'van der Ham DP, Vijgen SM, Nijhuis JG, van Beek JJ, Opmeer BC, Mulder AL, Moonen R, Groenewout M, van Pampus MG, Mantel GD, Bloemenkamp KW, van Wijngaarden WJ, Sikkema M, Haak MC, Pernet PJ, Porath M, Molkenboer JF, Kuppens S, Kwee A, Kars ME, Woiski M, Weinans MJ, Wildschut HI, Akerboom BM, Mol BW, Willekes C; PPROMEXIL trial group. Induction of labor versus expectant management in women with preterm prelabor rupture of membranes between 34 and 37 weeks: a randomized controlled trial. PLoS Med. 2012;9(4):e1001208. doi: 10.1371/journal.pmed.1001208. Epub 2012 Apr 24.'}, {'pmid': '19075469', 'type': 'BACKGROUND', 'citation': 'Zuo Y, Wang C, Zhou J, Sachdeva A, Ruelos VC. Simultaneous determination of creatinine and uric acid in human urine by high-performance liquid chromatography. Anal Sci. 2008 Dec;24(12):1589-92. doi: 10.2116/analsci.24.1589.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the relation between the concentration of urea and creatinine in vaginal fluid and length of latency period in women with PROM between 32 and 35 weeks gestation.', 'detailedDescription': '60 pregnant women with PROM with singleton pregnancies with a gestational age between 32- 35 gestational weeks History taking followed by examination All women will be put in dorsal lithotomy position, using a proper light source and sterile gloves; sterile speculum free of gel will be placed into vagina.\n\nFor every woman a specimen of vaginal fluid will be taken as follows: 5 ml of sterile saline solution will be injected into the posterior vaginal fornix taken after aspiration of 3ml with the same syringe.\n\nAll samples will be obtained within 6 hours after membranes rupture before vaginal examination and the administration of any drugs. Upon collection, samples were centrifuged at 3000 rpm for 10 minutes and supernatant fluid was separated. Exact concentrations of urea and creatinine will be measured\n\nAll women will be put under observation for 48 hours and time of onset of delivery will be documented, the onset of labor will be diagnosed by either:\n\n1. Frequent uterine contractions more than 2 contractions in 10 minutes.\n2. CTG showing frequent contractions.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'sixity pregnant women with PROM with singleton pregnancies with a gestational age between 32- 35 gestational weeks by reliable menstrual history and confirmed by pelvi-abdominal ultrasound.\n\nMembranes rupture will be diagnosed by the direct visualization of fluid leakage from the cervical canal using sterile speculum.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Maternal age between 20-35 years.\n2. 32-35 weeks gestational age.\n3. Viable fetus.\n\nExclusion Criteria:\n\n1. Vaginal bleeding either spontaneous or traumatic e.g. placenta previa.\n2. Chorioamnionitis.\n3. Multiple pregnancy.\n4. Presence of uterine contractions.\n5. Amniotic fluid disorders e.g. polyhydramnios\n6. Meconium stained amniotic fluid prior to active phase of labor.\n7. Maternal disease necessitating termination of pregnancy e.g. severe preeclampsia'}, 'identificationModule': {'nctId': 'NCT03213535', 'briefTitle': 'Urea and Creatinine Level in Vaginal Fluid as a Predicator for Length of Latency Period in Prelabour Membranes Rupture', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Urea and Creatinine Level in Vaginal Fluid as a Predicator for Length of Latency Period in Prelabour Membranes Rupture', 'orgStudyIdInfo': {'id': 'PRP-PROM'}}, 'contactsLocationsModule': {'locations': [{'zip': '+20', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'rasha m medhat abd el hady, MD', 'role': 'CONTACT', 'email': 'RASHAMEDHAT30@GMAIL.COM', 'phone': '1224448449', 'phoneExt': '002'}], 'facility': 'Ain Shams university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'rasha M Medhat Abd El-Hady, MD', 'role': 'CONTACT', 'email': 'RASHAMEDHAT30@GMAIL.COM', 'phone': '1224448449', 'phoneExt': '0020'}, {'name': 'Daniel O Anis, M.B., B.Ch.', 'role': 'CONTACT', 'email': 'dany.onsi@gmail.com', 'phone': '1272755335', 'phoneExt': '0020'}], 'overallOfficials': [{'name': 'rasha M Medhat Abd El-Hady, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ain Shams University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal Investigator Dr.rasha medhat abdul-hady', 'investigatorFullName': 'rasha medhat abdul-hady', 'investigatorAffiliation': 'Ain Shams University'}}}}