RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,



RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

BANGALORE,KARNATAKA.

ANNEXURE- II

PROFORMA OF REGISTRATION OF SUBJECT FOR DISSERTATION

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|1) |NAME OF THE CANDIDATE AND ADDRESS |MISS. ALPHONSA MATHEW |

| | |KAZHIKKACHALIL (H) |

| | |CHITTOOR |

| | |PUTHUPARIYARM (P.O) |

| | |THODUPUZHA |

| | |IDUKKI. KERALA. |

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|2) |NAME OF THE INSTITUTION |VISVESWARAPURA INSTITUTE OF PHARMACEUTICAL SCIENCES BANASHANKARI-II |

| | |STAGE BANGALORE-70 |

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|3) |COURSE OF THE STUDY AND |MASTER OF PHARMACY |

| |SUBJECT |IN |

| | |PHARMACY PRACTICE |

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|4) |DATE OF ADMISSION TO THE COURSE |16/05/2007 |

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|5) |TITLE OF THE TOPIC |STUDY OF ANTIMICROBIAL THERAPY PATTERN IN UTI IN PREGNANCY. |

|6 |BRIEF RESUME OF THE INTENDED WORK |

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| |6.1) NEED FOR THE STUDY: |

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| |A urinary tract infection (UTI), also called bladder infection, is a bacterial inflammation in the urinary tract.1 |

| |UTIs account for approximately 10 percent of office visits by women, and 15 percent of women will have a UTI at some |

| |time during their life. In pregnant women, the incidence of UTI can be as high as 8 percent.2, |

| | |

| |During pregnancy, bacterial growth is favored by the increased urinary content of amino acids, vitamins and other |

| |nutrients, which encourage the persistence of infection. Slowing of urine flow secondary to dilation of the urinary |

| |tract, which may be caused by hormonal and mechanical factors, can add to this effect.3 |

| | |

| |Escherichia coli is the most frequent pathogen, being reported in about 70-95% of cases. Other enterobacteriace and |

| |group B streptococci cause bacteriuria in pregnancy and several reports showed that Micrococcaceae are |

| |significalnt urinary tract pathogens in non-pregnant women.3 |

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| |UTI in pregnancy may result in low birth weight infants, premature delivery and occasionally stillbirth. It also causes|

| |pre-eclampsia, hypertension, anemia, & postpartum endometritis .3 |

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| |It is well documented that effective treatment of UTI’s significantly reduces the incidence of pyelonephritis, |

| |premature deliveries & low birth weight infants.3 |

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| |The practice of prescription of antibacterial drugs in pregnancy varies in different countries. |

| |Apart from economic arguments, the problem of selecting an antibacterial agent for treatment in pregnancy is the |

| |possible conflict between a well established drug that is well tolerated and empirically known to be harmless to the |

| |fetus, and a drug to which there is a low level of bacterial resistance3. |

| | |

| |So this study aims to know the prescribing pattern of antimicrobials in UTI patients in KIMS hospital. |

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| |6.2) REVIEW OF LITERATURE |

| |The term urinary tract infection (UTI) usually refers to the presence of organisms in the urinary tract together with |

| |symptoms, and some times signs, of inflammation. However it is more precise to use one of the following terms: |

| |Significant bacteriuria: defined as the presence of at least 1,00,000 bacteria per ml of urine. |

| |Asymptomatic bacteriuria: significant bacteria in the absence of symptoms in the patient. |

| |Cystitis: a syndrome of frequency, dysuria and urgency, which usually suggests infection restricted to the lower |

| |urinary tract (i.e. the bladder and urethra). |

| |Pylonephritis: an infection of one or both kidneys. |

| |Relapse and reinfection: recurrence of urinary tract infection may be due to either relapse or reinfection. Relapse is |

| |recurrence caused by the same organism that caused the original infection. Reinfection is recurrence caused by a |

| |different organism, and is therefore a new infection.4 |

| |Pregnant women are at increased risk for UTIs. Hydronephrosis of pregnancy, increased bladder volume and decreased |

| |bladder tone, along with decreased ureteral tone, contribute to increased urinary stasis and ureterovesical reflux. Up |

| |to 70 percent of pregnant women develop glycosuria, which encourages bacterial growth in the urine. Increases in |

| |urinary progestins and estrogens may lead to a decreased ability of the lower urinary tract to resist invading |

| |bacteria. This decreased ability may be caused by decreased ureteral tone or possibly by allowing some strains of |

| |bacteria to selectively grow. These factors may all contribute to the development of UTIs during pregnancy.2 |

| |A survey of physicians in Denmark, Finland, Norway and Sweden confirmed that beta-lactam antibiotics (particularly |

| |Pivmecillinam) and Nitrofurantoin are the drugs of first choice in the treatment of bacteriuria in pregnancy. No |

| |teratogenic effects have been associated with these agents. In contrast to Nitrofurantoin, Pivmecillinam is also |

| |efficient against pylonephritis. In spite of resistance in E.coli and possible adverse effects on the fetus, many |

| |physicians still prescribe Sulphonamides during the first two trimesters of pregnancy.3 |

| | |

| |In the study conducted by Elicia S Kennedy, the antibiotics used in treatment of UTI in pregnancy are Amoxicillin, |

| |Nitrofurantoin, Trimethoprim, Sulphamethoxazole, Cephalexin, Ceftriaxone, Cefazoline and Ceftibuten.5 |

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| |As per the university of Chicago medical center obstetrician/gynecologist were most likely to prescribe Nitrofurantoin,|

| |which is thought to be less likely to contribute to birth defects, but is not recommended in the specialty literature |

| |as a first – line treatment for urinary tract infections during pregnancy.6 |

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| |The Canadian compendium of pharmaceuticals and specialties continues to state that the Nitrofurantoin use is |

| |contraindicated in pregnancy when patients are close to delivery.7 |

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| |According to a study by Mathai E., Thomas R J., and Chandy S., Cephalosporins were most commonly used in hospital |

| |practice for the treatment of UTI. Amoxicillin was being used widely to treat UTI in pregnancy inspite of high |

| |prevalence of resistance. E.coli causing UTI is still susceptible to Nitrofurantoin, a relatively inexpensive and safe |

| |drug. However less than 25% of doctors used it in the treatment of cystitis. There were wide variations in the duration|

| |of therapy and use of prophylaxis.8 |

| | |

| |A study based on the practicing physicians participating in the National Ambulatory Medical care showed that the most |

| |frequently prescribed antibiotics were Trimethoprime & Sulfamethoxazole. They are increasing their use of |

| |Fluroquinolones and Nitrofurantoin. Antibiotics prescribing in urinary tract infections may be influenced by clinical |

| |factors such as pregnancy and drug allergies but may also be shaped by non clinical factors such as subspecialty |

| |culture. 9 |

| |According to a study conducted by Ochoa-Brust GJ and Fernandez AR it was concluded that daily intake of 100mg of |

| |ascorbic acid played an important role in the reduction of urinary infections, improving the health level of the |

| |gestating women.10 |

| | |

| |OBJECTIVES OF THE STUDY : |

| |To study the prescribing patterns of the antibiotics in the treatment of |

| |UTI during pregnancy |

| |2. Comparison between the treatment given for UTI in pregnant and non |

| |pregnant women. |

| |3. To create awareness regarding UTI, its recurrence and to provide |

| |counseling to the patient. |

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| |MATERIALS AND METHODS :- |

| |7.1 )Study design |

| |Hospital based prospective study |

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| |7.2) Source of Data : |

| |1. Patients visiting Department of OBG, KIMS hospital and Research Centre and provisionally diagnosed of UTI.|

| |Patient Case sheet and medications chart, lab reports etc. |

| |3. Patient interview |

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| |7.3) INCLUSION CRITERIA |

| |1. Pregnant and non pregnant patients who are diagnosed with UTI. |

| |2. Patients in the age group of 18 to 50 years |

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| |7.4) EXCLUSION CRITERIA |

| |1 . Patients who are reciving antimicrobial therapy for infections |

| |apart from UTI. |

| |Patients below 18 years of age. |

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| |7.5) Method and collection of Data : |

| |A prospective study will be conducted in outpatient OBG department of KIMS Hospital, on patients diagnosed with UTI. |

| |Demographic data of the patient, details on visit for the treatment (first or return), symptoms and duration, |

| |diagnostic technique and treatment with antimicrobials including type of drug, duration, route, dosage form and cost of|

| |the drug will be collected. |

| |Awareness regarding UTI will be provided by giving suitable counseling tips. |

| |The data collected will be analyzed statistically using ANOVA and Paired ‘t’ test |

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| |7.6)Duration of the study: |

| |The study will be conducted for a period of 6 months |

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| |7.7.Place of Study: |

| |Department of OBG, KIMS Hospital and Research centre, A tertiary |

| |teaching Hospital, Bangalore. |

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| |7.8) Does the study require any investigation or intervention to be conducted on patient or other humans or animals if|

| |so, please describe briefly. |

| |NO |

| |7.9) Has ethical clearance been obtained from your institution? |

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| |Yes (copy enclosed) |

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| |LIST OF REFERENCES |

| |American academy of family physician, urinary tract infection during |

| |pregnancy . Date: 09/11/07; 11:00 AM |

| |2) John E. Delzell ,JR, M.D,and Michaell L. Lefvre, M.D., M.S.P.H. Urinary |

| |Tract infections during pregnancy. Amarican family physician published |

| |By the amarican academy of family physicians vol. 61, no.3. feb. 1, 2000. |

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| |3) Benedict Christene Journal of antimicrobial chemotherapy (2000) 46, |

| |suppl. SI, 29-34. |

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| |4) A.J.Bint, A.W.Berrington. urinary tract infection. Clinical pharmacy and |

| |therapeutics edited by Roger Walker, Clive Edwards third edition. Page |

| |no: 533. |

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| |Elicia S Kennedy, MD, pregnancy, urinary tract infections. Aug. 8, 2007. |

| |. |

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| |6) The university of Chicago medical center: Antibiotic prescription patters |

| |violateguidelines, increase costs. January 13, 2002. |

| |. |

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| |7) Nevio Cimolai and Tomas Cimolai , canadian medical association |

| |Nitrofurantoin and pregnancy. CMAJ. 2007 June 19; 176(13): 1860–1861. |

| | |

| |8) Mathai E.,Thomas R.J,& Chandy S. Antimicrobials for the treatment of |

| |urinary tract infection in pregnancy : practices in southern India. |

| |Pharmacoepidemiol drug saf. 2004 Sep: 13(9):645-52. |

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| |9) Elbert S.Huang, MD, MPH; Randall S. Safford, MD, PhD. National |

| |patterns in the treatment of urinary tract infections in women by |

| |ambulatory care physicians. Arch inter med/vol 162. jan 14, 2002. |

| |. |

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| |10) Ochoa-Brust GJ and Fernandez AR daily intake of 100mg ascorbic acid as |

| |urinary tract infection prophylactic agent during pregnancy.Acta Obstet |

| |gynecol scand. 2007: 86(7): 783-7. |

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|8.0 | |

|9.0 |Signature of the candidate | |

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|10.0 |Name and designation of the guide |Mrs. Meera N. K. |

| | |Assistant Professor |

| | |VIPS, Bangalore. |

|10.1 |Remarks of the guide | |

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|10.2 |Signature of the guide | |

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|11.0 |Name of the head of the department |Mrs. Githa Kishore |

| | |Assistant Professor |

| | |VIPS, Bangalore |

|11.1 |Signature of the head of the department | |

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|11.2 |Name and designation of co-guide |Dr. Harsha |

| | |Assistant Professor |

| | |Department of OBG |

| | |KIMS,Bangalore. |

|11.3 |Signature of the Co-guide | |

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|12.0 |Name of the Principal |Dr. Kalyani Prakasam, |

| | |M.Pharm, PhD |

|12.1 |Signature of Principal | |

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