6. BRIEF RESUME OF THE INTENDED STUDY:
6.1 Need for the study:
Female Reproductive tract infections (FRTIs) are being increasingly recognized as a serious global health problem with impact on individual women, their families and communities. FRTIs entail a heavy toll on women, if untreated they can lead to pelvic inflammatory disease (PID), which can cause long-term sequelae, such as tubal infertility, ectopic pregnancy, chronic pelvic pain and abortions.1
World Health Organization estimates that each year there are over 340 million new cases of FRTIs in which 75-85% occur in developing countries. In India alone, 40 million new cases emerge each year.2 Studies done on women in developing countries have found FRTIs ranging from 52-92 percent and fewer than half women recognized the condition as abnormal.
Although a handful of studies have shown that monotherapies for FRTIs achieve high rates of clinical cure, the efficacy of these regimens in preventing adverse reproductive sequelae is not fully elucidated.
Accordingly, in view of the aforementioned observations, this prospective study envisages compilation, analysis of the pattern, trend, rationality and frequency of the use of drugs in the treatment of FRTIs, with emphasis on available treatment regimens inclusive of primary and adjunctive therapy.
6.2 Review of literature :
Female Reproductive tract infections (FRTIs) are a major public health concern leading to profound gynaecological morbidity among women in reproductive age group. FRTIs include 3 different types of infections that affect the reproductive tract namely endogenous infections, sexually transmitted infections and iatrogenic infections. 3 FRTIs are often categorized by the site of infection. Accordingly, the clinical entities such as vulvo-vaginitis [or vaginitis] and cervicitis are included under Lower reproductive tract infections, while pelvic inflammatory disease (PID) constitute the Upper reproductive tract infection in women.
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The overall prevalence of clinically diagnosed FRTIs showed variations depending upon the geographical areas, nature and site of infection, and also the criteria used for diagnosis. A few community based studies reported from various parts of India have showed the prevalence of Reproductive tract infections among reproductive women as 40.4 percent in Karnataka4, 26 percent in Baroda to 74 percent in Mumbai.5
Vaginitis is perhaps the most common FRTI. If not treated, vaginitis has the potential to cause greater complications. Vaginitis is treated by metronidazole, cephalosporins, clindamycin and azole group of antimicrobials, depending on its cause.6
Marrazo et al reported a possible association between bacterial vaginosis (BV) and cervicitis, independent of concomitant chlamydial and gonococcal infection. Moreover, antimicrobials used in the treatment of BV for women with cervicitis were associated with enhanced rates of resolution of cervicitis.7
In 27 percent of women with evidence of lower genital tract infections, histological evidence of endometritis was seen.8 Therefore, the choice of antimicrobial therapy for cervicitis should also cover endometritis. Fortunately, Eckert et al., showed that a short course of an oral antimicrobial regimen consisting of single-dose cefixime 400 mg, single-dose azithromycin 1 g and metronidazole 500 mg twice daily for 7 days was highly effective (89%) in leading to the resolution of histologic endometritis.9
In 2007-2008 the Gonococcal Antimicrobial Surveillance Programmes conducted by the World Health Organization in the Western Pacific and South East Asian Regions reported Quinolone Resistant Nisseria Gonorrhoea (QRNG) in nearly 100% of isolates examined in Hong Kong and the Mainland China.10 Ceftriaxone, doxycycline, azithromycin and metronidazole are the important drugs used in the treatment of QRNG infections.
Between 1992 and 2006, 5 randomized clinical trials of moxifloxacin (1 trial), ofloxacin (1 trial), clindamycin-ciprofloxacin (1 trial), and azithromycin (2 trials) treatment among women with mild to moderate PID were found to have clinical cure rates of 90%–97%.11 Women with clinically severe PID should be admitted to hospital for imaging to rule out tubo–ovarian abscess and be started on parenteral therapy utilizing an antimicrobial regimen that will remain active within an abscess environment.
The Pelvic Inflammatory Disease Evaluation And Clinical Health Randomized Trial (PEACH) provides the best guidance regarding the antimicrobial therapy of women with mild-to-moderate PID. In this large, multicentered, prospective randomized trial it was concluded that a single dose of cefoxitin, which has good activity against Gram-negative anaerobes, and multiple doses of doxycycline, despite suboptimal activity against anaerobic bacteria, are sufficient for clinical cure and apparently do not adversely affect long-term outcome comparatively.12
Optimal therapy for FRTIs must take into consideration the severity of disease, the polymicrobial etiology of disease, the availability and costs of the drugs, and their ease of administration. This study evaluates/analyses the current trend in the treatment of FRTIs and its rationality.
6.3 objectives of the study:
(a) To analyze/evaluate the trend and pattern of drug prescriptions for FRTIs in a
teaching hospital.
(b) To study the rationality of specific and adjunctive drug therapy.
(c) To monitor adverse effects, if any, subject to compliance of the patients.
7. MATERIALS AND METHODS:
7.1 source of data:
Medical case records of female patients suffering from Reproductive tract infections attending the department of OBG (Obstetrics and Gynaecology) will be the source of data and the data are recorded in a specially designed proforma.
7.2 method of data collection:
This study seeks to record the relevant data prospectively and will be carried out at the KVG Medical college Hospital, Sullia, for a period of 15-18 months(1st october 2012 to 31st march 2014), with the assistance/coordination of gynaecologists and other hospital staff in the outpatient department and wards.
Thus, a specially designed proforma will be used for data collection, under the following headings.
1. Demographic data:
Name, age, address, OP/IP number, date of examination/admission of patients.
2. Disease data:
Type and duration of FRTIs
3. Data pertaining to drug therapy:
Drug/Drugs prescribed, dose, frequency, duration and route of administration.
4. Data pertaining to investigations:
Culture and sensitivity tests, if any,
5. Data pertaining to adverse effects of drugs, if any.
Inclusion criteria: Female Patients suffering from Reproductive Tract Infections reporting at K.V.G medical college hospital, Sullia (D.K)
Exclusion criteria:
Female patients suffering from urinary tract infections.
Pregnancy.
Analysis of Data:
Statistical analysis will be done using appropriate formulae.
7.3 Does the study require investigation/intervention to be conducted on patients/humans/animals? If so, please describe.
NO
7.4 Has ethical clearance been obtained from your institution in case of 7.3?
Not applicable.
Followup
Not applicable.
Followup period
Not applicable.
8. LIST OF REFERENCES :
1. Westrom L, Joesoef R, Reynolds G, Hagdu A, Thompson SE. Pelvic inflammatory disease and fertility- A cohort study of 1,844 women with laparoscopically verified disease and 657 control women with normal laparoscopic results. Sex Transm Dis 1992; 19:185-92.
2. Aggarwal D. Reproductive tract infections - challenges and responses; Health for the Millions 2001;3:21-3.
3. Salhan S, puri P, Ramesh V.Reproductive tract infections and sexually transmitted diseases (RTIs and STDs). In: Salhan S, author.Textbook of gynecology. New Delhi: Jaypee Brothers Medical Publishers; 2011. p. 241-51.
4. Balamurugan SS, Bendigeri ND. Community-based study of reproductive tract infections among women of the reproductive age group in the urban health training centre area in Hubli, Karnataka. Indian J Community Med 2012; 37(1): 34-8.
5. Latha K, Kanani SJ, Maitra N, Bhatt RV, Senapati SK, Bhattacharya S, et al. Prevalence of clinically detectable gynaecological morbidity in India: results of four community based studies. J Family Welfare1997;43(4):8-16.
6. Dutta DC. Infections of the individual pelvic organs. In: Konar H, editor. Textbook of gynaecology. Kolkata: New central book agency (p); 2008. 5th ed. p.158-62
7. Marrazzo JM, Wiesenfeld HC, Murray PJ, Busse B, Meyn L, Krohn M, et al. Risk factors for mucopurulent cervicitis among women with bacterial vaginosis. J Infect Dis 2006; 193:617–24.
8. Wiesenfeld HC, Hillier SL, Krohn MA, Amortegui AJ, Heine RP, Landers DV
et al. Lower genital tract infection and endometritis: insight into subclinical pelvic inflammatory disease. Obstet. Gynecol 2002; 100(3): 456–63.
9. Eckert LO, Thwin SS, Hillier SL, Kiviat NB, Eschenbach DA. The antimicrobial treatment of subacute endometritis: a proof of concept study. Am. J. Obstet. Gynecol2004; 190(2): 305–13.
10. Tapsall JW, Limnios EA, Abu Bakar HM, Darussalam B, Ping YY, Buadromo EM, et al. Surveillance of antibiotic resistance in Neisseria gonorrhoeae in the WHO Western Pacific and South East Asian regions,2007-2008.Commun Dis Intell 2010 Mar; 34(1):1-7
11. Haggerty CL, Ness RB. Newest Approaches to Treatment of Pelvic Inflammatory Disease: A Review of Recent Randomized Clinical Trials. Clinical Infectious Diseases 2007; 44:953–60
12. Ness RB, Soper DE, Holley RL, Peipert J, Randall H, Sweet RL, et al. Effectiveness of inpatient and outpatient treatment strategies for women with pelvic inflammatory disease: results from the Pelvic Inflammatory Disease Evaluation and Clinical Health (PEACH) Randomized Trial. Am. J. Obstet. Gynecol2002; 186: 929-37
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