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CTRI Trial Data PDF of Trial CTRI Website URL - http://ctri.nic.in Clinical Trial Details (PDF Generation Date :- Wed, 29 Sep 2021 11:43:48 GMT) CTRI Number CTRI/2016/09/007240 [Registered on: 06/09/2016] - Trial Registered Prospectively Last Modified On 11/12/2019 Post Graduate Thesis Yes Type of Trial Observational Type of Study Follow Up Study Study Design Other Public Title of Study Finding usefulness of a new quick test for detecting infection in urine of pregnant women Scientific Title of Evaluation of rapid strip test for screening bacteriuria among pregnant women and its effect on Study incidence of low birth weight and prematurity in new-borns Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Dr Manish Gehani Trial Coordinator (multi-center study) Designation PhD Scholar Affiliation Birla Institute of Technology and Science, Pilani, Hyderabad Campus Address Jawahar Nagar, Shameerpet Mandal, Hyderabad, Telangana Hyderabad ANDHRA PRADESH 500078 India Phone 7568874444 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Prof Suman Kapur Query) Designation Head of Department Affiliation Birla Institute of Technology and Science, Pilani, Hyderabad Campus Address Room no 101, A Block, Birla Institute of Technology and Scinece, Pilani, Hyderabad Campus, Jawahar Nagar, Shameerpet Mandal, Hyderabad, Telangana 500078 Hyderabad ANDHRA PRADESH 500078 India Phone 9024618038 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr Manish Gehani Designation PhD Scholar Affiliation Birla Institute of Technology and Science, Pilani, Hyderabad Campus Address Jawahar Nagar, Shameerpet Mandal, Hyderabad, Telangana Hyderabad ANDHRA PRADESH 500078 India Phone 7568874444 Fax page 1 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Birla Institute of Technology and Science, Pilani, Hyderabad Campus, Jawahar Nagar, Shameerpet Mandal, Hyderabad, Telangana 500078 > Gandhi Medical College and Hospital, Walker town, MIGH Colony, Padmarao Nagar, Secunderabad, Telangana 500003 Primary Sponsor Primary Sponsor Details Name Dr Manish Gehani Address Department of Biological Sciences, Birla Institute of Technology and Science, Pilani, Hyderabad Campus, Jawahar Nagar, Shameerpet Mandal, Hyderabad, Telangana 500078 Type of Sponsor Other [SELF] Details of Secondary Name Address Sponsor HOD Dr K Nagamani HOD Chamber, Department of Microbiology, Fourth Floor, Academic Building, Gandhi Medical College and Hospital, Walker town, MIGH Colony, Padmarao Nagar, Secunderabad, Telangana 500003 HOD Prof Suman Kapur Room no 101, A Block, Birla Institute of Technology and Scinece, Pilani, Hyderabad Campus, Jawahar Nagar, Shameerpet Mandal, Hyderabad, Telangana 500078 Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr K Nagamani Gandhi Medical College HOD Chamber, 9966533327 Hospital Microbiology Laboratory, Department nagamaniy2k03@rediff of Microbiology, Fourth mail.com Floor, Main Building, Gandhi Medical College and Hospital, Walker town, MIGH Colony, Padmarao Nagar, Secunderabad, Telangana 500003 Hyderabad ANDHRA PRADESH Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Institutional Ethics Approved 21/06/2016 No Committee, Gandhi Medical College, Secunderabad Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Patients Pregnant mothers Patients Unspecified infection of urinary tract in pregnancy Intervention / Type Name Details page 2 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in Comparator Agent Intervention Rapid Strip Test Urine collected from patient is subjected to a test based on veil assay and liquid media detecting bacteria by chromogenicity on strips prepared for the same Comparator Agent Conventional Urine Culture and urine is streaked on plates and Sensitivity incubated for colonies which are subjected to antibiotic sensitivity Inclusion Criteria Inclusion Criteria Age From 15.00 Year(s) Age To 44.00 Year(s) Gender Female Details 1.Pregnant women attending ANC checkups<br/> 2.All trimesters<br/> 3.All parity<br/> 4.Symptomatic UTI as well as asymptomatic mothers Exclusion Criteria Exclusion Criteria Details 1.Non pregnant women attending hospital for other reasons 2.Women who have received antibiotics in the last two weeks 3.Women pregnant for more than 38 weeks 4.Women screened with the tests already in any other arm Method of Generating Coin toss, Lottery, toss of dice, shuffling cards etc Random Sequence Method of Other Concealment Blinding/Masking Open Label Primary Outcome Outcome Timepoints Positive test results for detecting urinary tract 6 months infection by either urine culture or strip test Secondary Outcome Outcome Timepoints Incidence of pregnancy outcomes of low birth 15 months weight and prematurity on follow up Rate of repeated infections on follow up 15 months Target Sample Size Total Sample Size=500 Sample Size from India=500 Final Enrollment numbers achieved (Total)=2226 Final Enrollment numbers achieved (India)=2226 Phase of Trial N/A Date of First 03/10/2016 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=2 Trial Months=4 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Completed Trial (India) Publication Details Kapur, S.; Gehani, M.; Kammili, N.; Bhardwaj, P.; Nag, V.; Devara, S.M.; Sharad, S. Clinical Validation of Innovative Optical-Sensor-Based, Low-Cost, Rapid Diagnostic Test to Reduce page 3 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in Antimicrobial Resistance. J. Clin. Med. 2019, 8, 2098. Brief Summary Urine sample and data regarding socioeconomic, demography, clinical signs and symptoms and antenatal data will be collected from pregnant mothers satisfying inclusion exclusion criteria. Same number of asymptomatic and symptomatic UTI mothers will be enrolled. Each sample will be subjected to conventional urine culture test and a clinical microbiology test based on veil assay, liquid medium and chromogenicity in the lab and the results of the two test will be compared separately in asymptomatic and symptomatic mothers. The pregnant women will be observed and followed up till the outcome of pregnancy for incidence of prematurity and low birth weight and repeated urinary tract infections. The incidence in women diagnosed for asymptomatic bacteriuria with strip test and conventional tests and in those not diagnosed by these tests will be compared. page 4 / 4 Powered by TCPDF (www.tcpdf.org).
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