1 - Rajiv Gandhi University of Health Sciences
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES
KARNATAKA, BANGALORE
ANNEXURE – I
SYNOPSIS SUBMISSION
MD PHARMACOLOGY
RAJARAJESWARI MEDICAL COLLEGE
AND HOSPITAL, BANGALORE - 560074
“A PROSPECTIVE STUDY OF
ANTIMICROBIAL PROPHYLAXIS IN LOWER SEGMENT CESAREAN SECTION IN
A TERTIARY CARE HOSPITAL”
By
DR. NAVEEN POOJAR C M
PG in Pharmacology
Department of Pharmacology
Rajarajeswari Medical College
And Hospital, Bangalore – 560074
Guide: Dr. BASAVARAJ BHANDARE
Prof & HOD
Dept of Pharmacology
Rajarajeswari Medical College and Hospital, Bangalore
Co- guide: Dr. NAGARATHNAMMA
Prof & HOD
Dept of OBG
Rajarajeswari Medical College and Hospital, Bangalore
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA, BANGALORE
ANNEXURE – II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
|1 | | | |
| |Name of the candidate and address |: |Dr. NAVEEN POOJAR C M |
| |(in block letters) | | |
| |Permanent address | | |
| | |: |#130, 2ND CROSS, |
| | | |2ND MAIN, SUNKADAKATTE, |
| | | |BANGALORE-560091 |
|2 |Name of the institution | | |
| | |: |RAJARAJESWARI MEDICAL |
| | | |COLLEGE AND HOSPITAL, |
| | | |BANGALORE |
|3 |Course of study and subject | | |
| | |: |MD, PHARMACOLOGY |
|4 |Date of admission to the course | | |
| | |: |30TH MAY 2012 |
|5 |Title of Topic | | |
| | | |“A PROSPECTIVE STUDY OF |
| | |: |ANTIMICROBIAL PROPHYLAXIS IN LOWER SEGMENT CESAREAN SECTION IN |
| | | |A TERTIARY CARE HOSPITAL” |
|6 |Brief Resume of the intended work |
| |6.1 |Need for the study |
| | | |
| | |Lower segment Cesarean section is the most common surgical procedure done in the department of Obstetrics. The rates averaging |
| | |greater than 20% in the developing countries. Women undergoing Cesarean delivery have a 5 to 20 fold greater risk of infection |
| | |compared with Vaginal delivery.1 |
| | | |
| | |Infectious complications includes fever, wound infection, endometritis, bacteremia, UTI and other serious infections (including |
| | |pelvic abscess, septic shock, necrotizing fascitis, and septic pelvic vein thrombophlebitis).1 These complications not only |
| | |results in increased hospital stay but also increase in the cost of care. |
| | | |
| | |Prophylactic antimicrobials are proved to be effective in lowering post operative infections both in women at high risk (in labour |
| | |after membrane rupture), and low risk (non-labouring with intact membrane). They are often administered after umbilical cord |
| | |clamping. This administration of drug shortly after cord clamping is considered to be as effective as administrating the drug |
| | |preoperatively.2 |
| | | |
| | |The current debate focuses on the choice of antimicrobials and the timing of administration. With respect to timing, the debate lies|
| | |between pre-incision or after clamping of the umbilical cord and the choice of antimicrobial lies between narrow-range and |
| | |broad-spectrum. Both of these debates have been influenced by concerns that broad spectrum antimicrobials given before incision |
| | |might mask neonatal infection or result in a neonatal infection in which no organism could be cultured. There are also concerns |
| | |that the wrong choice of antimicrobial may result in the neonate being exposed to resistant strains of bacteria, which might lead to|
| | |a worse neonatal outcome or the need for expensive neonatal septic screens and infection work-ups. |
| | | |
| | |Antimicrobial resistance development results mainly from the inappropriate use of antimicrobials. Incomplete courses of |
| | |antimicrobial therapies and the unnecessary use of broader spectrum regimens play a role. Adherence to both treatment and |
| | |prophylaxis guidelines likely assists in reducing infection and antimicrobial resistance. |
| | | |
| | |Documented guidelines regarding antimicrobial prophylaxis for lower segment cesarean section has not been established in our |
| | |hospital. Therefore this study is aimed to evaluate prophylactic antimicrobial use with regards to choice of antimicrobials, |
| | |dosage, route, timing and duration of antimicrobial prophylaxis and to assess the frequency of the post operative morbidity. |
| |6.2 |Review of Literature |
| | | |
| | |The most important risk factor for postpartum infection in women is cesarean delivery.(1) Rates of infectious morbidity after |
| | |cesarean delivery, including postpartum endometritis and wound infection, range from 3–20%.3 |
| | | |
| | |Factors that have been associated with an increased risk of infection and infectious morbidity among women who have a cesarean |
| | |delivery include emergency cesarean section, labor and its duration, ruptured membranes and the duration of rupture, the |
| | |socioeconomic status of the woman, number of prenatal visits, vaginal examinations during labor, urinary tract infection, anemia, |
| | |blood loss, obesity, diabetes, development of subcutaneous hematoma, the skill of the operator and the operative technique.1 |
| | | |
| | |The association of bacterial vaginosis with an increased incidence of endometritis following cesarean birth has also been reported. |
| | |The most important source of micro-organisms responsible for post-cesarean section infection is the genital tract, particularly if |
| | |the membranes are ruptured. Even in the presence of intact membranes, microbial invasion of the intrauterine cavity is common, |
| | |especially with preterm labor. 4 |
| | | |
| | |Infections are commonly polymicrobial (caused by many organisms). Pathogens isolated from infected wounds and the endometrium |
| | |include Escherichia coli, group B streptococcus, Enterococcus faecalis, Staphylo- coccus aureus and coagulase negative |
| | |staphylococci, anaerobes (including Peptostreptococcus species and Bacteroides species), Gardnerella vaginalis and genital |
| | |mycoplasmas. 5 |
| | | |
| | | |
| | |Antimicrobial prophylaxis at the time of surgery has reduced the rate of postpartum endometritis and wound infection after both |
| | |nonelective and elective cesarean delivery.6 Without prophylaxis, the incidence of endometritis is reported to range from 20% to |
| | |85%; rates of wound infection and serious infectious complications as high as 25% have been reported.7 |
| | | |
| | |Antimicrobial agents for surgical prophylaxis often are administered after umbilical cord clamping. Withholding antimicrobial |
| | |administration until cord clamping avoids transplacental delivery of antibiotics to the fetus, reducing the concern of masking |
| | |neonatal infections or affecting microbiologic cultures of the neonate. However, the timing of administration has been recognized to|
| | |influence the efficacy of antimicrobial prophylaxis.8 |
| | | |
| | |Classen et al 9 demonstrate that prophylactic antimicrobials are most effective when administered within one hour before incision, |
| | |with surgical infection rates rising if antimicrobials are administered after the surgical incision. Despite evidence that the |
| | |reduction of surgical- site infections is greater when antimicrobial prophylaxis is administered before rather than after skin |
| | |incision, common obstetrical practice is to delay antimicrobial prophylaxis until clamping of the neonate’s umbilical cord.6 |
| | | |
| | |A single dose of antimicrobial prophylaxis is as effective as multiple doses given perioperatively,10 and the routine use of |
| | |prophylactic antimicrobial s reduces the risk of infection by more than 50% . |
| | | |
| | |The ACOG ( American College of Obstetricians and Gynecologists) recommend narrow-range first-generation cephalosporins, like |
| | |cefazolin, to be administered after umbilical cord-clamping for prophylaxis against infection after Cesarean delivery. This is |
| | |because they are considered equally effective and less costly than broadspectrum antibiotics.11 |
| | | |
| | |As per the American Society of Health-System Pharmacists (ASHP) guidelines the prophylactic antimicrobial drug should achieve the |
| | |following goals |
| | |Prevent postoperative infection of the surgical site |
| | |Prevent postoperative infectious morbidity and mortality |
| | |Reduce the duration and cost of health care |
| | |Produce no adverse effects |
| | |Have no adverse consequences for the microbial flora of the patients or the hospital. |
| | | |
| | |Despite evidence, there has been very few studies on how doctors prescribe antimicrobial prophylaxis to patients who have had |
| | |cesarean section. Because of the rising costs in health care, lack of uniformity in prescribing attitudes and the emergence of |
| | |antimicrobial resistance, monitoring and controlling antibiotic use is needed.12 |
| | | |
| | |A clear antibiotic policy is essential for preventing the rapid and wide- spread development of resistance, focussed on empirical |
| | |antibiotic therapy, prophylactic and long-term use of antibiotics.13 Hence antimicrobial use has to be streamlined and the only way |
| | |to achieve the goal is to introduce antibiotic guidelines in every hospital. |
| | | |
| |6.3 |Objectives of the study |
| | | |
| | |1. To evaluate the pattern of Antimicrobial prophylaxis in Lower segment Cesarean section. |
| | | |
| | |2. To assess the frequency of post operative morbidity. |
| | | |
|7 |Materials and methods |
| |7.1 |Source of data |
| | | |
| | |Patients undergoing lower segment cesarean section (elective and emergency) in the department of Obstetrics in Rajarajeswari |
| | |medical college and hospital, Bangalore |
| | | |
| | | |
| |7.2 |Methods of collection of data |
| | |(including sampling procedure, if any) |
| | | |
| | |After taking Clearance and approval from Institutional Ethical committee a prospective observational study will be conducted in the|
| | |department of Obstetrics, Rajarajeshwari Medical College and Hospital. In our study, the calculated number of sample size is found |
| | |to be 245, rounded off to 250 based on 20% prevalence rate of lower segment cesarean section. The patients undergoing lower segment|
| | |cesarean section (elective and emergency) will observed from the period of 1st dose of antimicrobial prophylaxis till the patient |
| | |is discharged. |
| | | |
| | |Calculation : |
| | |Formula: n=(1.96)2pq/l2 |
| | |n= sample size. |
| | |p=prevalence rate |
| | |q= (1-p) |
| | |l= allowable error |
| | |p= 20% ; l=5% |
| | |using the above mentioned formula, |
| | |n= 1.96x1.96x20x80/5x5 = 245.8 |
| | | |
| | | |
| | |Relevant data will be collected on a proforma which is designed according to the protocol of the study. |
| | |which includes |
| | |a. Demographic profile of the patient |
| | |b. Socio-economic status of the patient. |
| | |c. Haemoglobin levels |
| | |d. Details of choice of antimicrobials. |
| | |e.Dose, dosage, duration, timing of administration, route of administration of antimicrobials. |
| | |f. Changes in the antimicrobials following culture and sensitivity. |
| | |g. Post operative infections and complications. |
| | | |
| | | |
| | |Inclusion criteria |
| | | |
| | |Patients undergoing |
| | |Elective Lower segment Cesarean section |
| | |Emergency Lower segment Cesarean section |
| | | |
| | |in the department of Obstetrics in Rajarajeswari Medical college and Hospital, Bangalore. |
| | | |
| | | |
| | |Exclusion criteria |
| | | |
| | |Patients who received antibiotics for any associated conditions in preceding 2 weeks of surgery. |
| | |Patients with comorbid conditions like Diabetes Milletus, Autoimmune diseases, Tuberculosis, HIV infections or Prophylaxis for |
| | |Rheumatic fever. |
| | |Patients on Chemotherapy, radiotherapy, long term steroids, or immunosuppresants. |
| | | |
| | | |
| | |Statistical Methods involved |
| | | |
| | |The data collected will be analyzed statistically using descriptive statistics namely mean and standard deviation for quantitative |
| | |variables and the causal relationship will be examined using either chi-square test or t-test. Wherever necessary, the results will|
| | |be depicted in the form of percentages and graphs. |
| | | |
| |7.3 |Does the study require any investigation or intervention to be conducted on patients or other humans or animals? if so please |
| | |describe briefly |
| | | |
| | |No, this study will only be an observational study. It does not require any Animal studies. |
| | | |
| |7.4 |Has ethical clearance been obtained from your institution in case of 7.3 ? |
| | | |
| | | |
| | |Yes |
| | |
|8 |List of References |
| | |
| |1. Gibbs RS. Clinical risk factors for puerperal infection. Obstet Gynecol 1980;55:178S–84. |
| | |
| |2.Gordon, H. R., D. Phelps, and K. Blanchard. 1979. Prophylactic cesarean section antibiotics: maternal and neonatal morbidity before or after cord|
| |clamping. Obstet. Gynecol. 53:151-156. |
| | |
| |3. Henderson E, Love EJ. Incidence of hospital-acquired infections associated with caesarean section. J Hosp Infect 1995;29: 245–55. |
| | |
| |4 .Watts DH, KrohnMA,Hillier SL, Eschenbach DA. The association of occult amniotic fluid infection with gestational age and neonatal outcome among |
| |women in preterm labor. Obstetrics and Gynecology 1992;79:351–7. |
| | |
| |5. Martens MG, Kolrud BL, Faro S, Maccato M, Hammill H. De-velopment of wound infection or separation after cesarean deliv-ery. Prospective |
| |evaluation of 2,431 cases. Journal of Reproductive Medicine 1995;40:171–5. |
| | |
| |6. Smaill F, Hofmeyr GJ. Antibiotic prophylaxis for cesarean section. The Cochrane Database of Systemic R views 2002, Issue 3. Art. No.: CD000933. |
| |DOI: 10.1002/ 14651858.CD000933. |
| | |
| |7. Enkin MW, Enkin E, Chalmers I,Hemminki E. Prophylactic antibi- otics in association with caesarean section. In:ChalmersI, EnkinMW, KeirseMJNC |
| |editor(s). Effective Care in Pregnancy and Childbirth. Oxford: Oxford University Press, 1989:1246–69. |
| | |
| |8. Page CP, Bohnen JM, Fletcher JR, McManus AT, Solomkin JS, Wittmann DH. Antimicrobial prophylaxis for surgical wounds. Guidelines for clinical |
| |care [published erratum appears in Arch Surg 1993;128:410]. Arch Surg 1993;128:79–88 |
| | |
| |9.Classen DC, Evan RS, Pestotnik SL, Horn SD, Menlove RL, Burke JP. The timing of prophylactic administration of antibiotics and the risk of |
| |surgical-wound infection. N Engl J Med 1992;326:281–6. |
| | |
| |10. Hawrylyshyn PA, Bernstein P, Papsin FR. Short-term antibiotic prophylaxis in high-risk patients following cesarean section. Am J Obstet Gynecol|
| |1983;145:285–9. |
| | |
| |11. American College of Obstetricians and Gynecologists. ACOG practice bulletin number 47, October 2003: Prophylactic antibiotics in labor and |
| |delivery. Obstet Gynecol 2003; 102:875–82. |
| | |
| |12. Kunin CM, Tupasi T, Craig WA. Use of antibiotics: A brief exposition of the problem and some tentative solutions. Ann Intern Med 1973; |
| |79:555-60. |
| | |
| |13. Man P, Verhoeven BAN, Verbrugh HA, Vos MC, van den Anker JN. An antibiotic policy to prevent emergence of resistant bacilli. Lancet 2000; 355: |
| |973-8. |
| | |
| | |
| | | |
|9 |Signature of Candidate | |
| | | |
| | | |
| | | |
| | | |
| | | |
|10 |Remarks of guide | |
| | | |
| | | |
| | | | |
|11 |11.1 |Name and designation of the Guide |Dr. BASAVARAJ BHANDARE |
| | | |Prof & HOD |
| | | |Dept of Pharmacology |
| | | |Rajarajeswari Medical College and Hospital, Bangalore |
| | | | |
| | | | |
| |11.2 |Signature | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | |Dr. NAGARATHNAMMA |
| |11.3 |Co- guide (if any) |Prof & HOD |
| | | |Dept of OBG |
| | | |Rajarajeswari Medical College and Hospital, Bangalore |
| | | | |
| | | | |
| | | | |
| |11.4 |Signature | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| |11.5 |Head of the Department |Dr. BASAVARAJ BHANDARE |
| | | |Prof & HOD |
| | | |Dept of Pharmacology |
| | | |Rajarajeswari Medical College and Hospital, Bangalore |
| | | | |
| | | | |
| | | | |
| |11.6 |Signature | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
|12 |12.1 |Remarks of the Chairman and Principal | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| |12.2 |Signature | |
| | | | |
| | | | |
| | | | |
| | | | |
PROFORMA
1. IP Number :
2. Name & Address :
3. Age :
4. Date Of Admission :
5. Date Of Discharge :
6. Socioeconomic Status :
7. Diagnosis :
8. Type Of Surgery (Elective/Emergency) :
9. Date & Time Of Surgery :
10. Prophylaxis Given :
|Antibiotic Given | | | |
|Dose & Dosage Schedule | | | |
|Route | | | |
|Date & Time | | | |
|Duration | | | |
|Change In Route( If Any) & Date Of Change | | | |
11. Any Change Of Antibiotic : Yes/No\
If Yes Reason For Change :
|Antibiotic Given & Date Of Change | | | |
|Dose & Dosage Schedule | | | |
|Route | | | |
|Duration of Administration | | | |
12.Post Operative Complications If Any: Yes/No
Wound Infection UTI Pelvic Abscess
Septicemia Endometritis Thrombophlebitis
Any Other (Specify)
13. Investigations :
A. Routine : Hb :
Blood Grouping :
Urine-Albumin :
Sugar :
Microscopy :
HIV (Type 1&2) :
HBsAg :
B. Urine C/S :
C. Pus C/S :
D. Blood C/S :
E. Any Other Relevant Investigations:
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