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   2014| July-December  | Volume 4 | Issue 2  
    Online since July 15, 2014

 
 
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REVIEW ARTICLE
Biosimilar drugs: Current status
Rajiv Kumar, Jagjit Singh
July-December 2014, 4(2):63-66
DOI:10.4103/2229-516X.136774  PMID:25143877
Biologic products are being developed over the past three decades. The expiry of patent protection for many biological medicines has led to the development of biosimilars in UK or follow on biologics in USA. This article reviews the literature on biosimilar drugs that covers the therapeutic status and regulatory guidelines. Appraisal of published articles from peer reviewed journals for English language publications, search from PubMed, and guidelines from European Medicines Agency, US Food Drug Administration (FDA) and India were used to identify data for review. Literature suggest that biosimilars are similar biological products, i.e., comparable but not identical to the reference product, are not generic version of innovator product and do not ensure therapeutic equivalence. Biosimilars present more challenges than conventional generics and marketing approval is also more complicated. To improve access, US Congress passed the Biologics Price Competition and Innovation act 2009 and US FDA allowed "abbreviated pathway" for their approval. U.S law has defined new standards and terms and EMA scientific guidelines have also set detailed approval standards. India being one of the most preferred manufacturing destinations of biosimilars, there is a need for stringent safety and regulatory guidelines. The New India Guidelines "Draft Guidelines on Similar Biologics were announced in June 2012, by Department of Biotechnology at Boston bio and available online.
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ORIGINAL ARTICLES
Dexmedetomidine versus esmolol to attenuate the hemodynamic response to laryngoscopy and tracheal intubation: A randomized double-blind clinical study
Siddareddigari Velayudha Reddy, Donthu Balaji, Shaik Nawaz Ahmed
July-December 2014, 4(2):95-100
DOI:10.4103/2229-516X.136788  PMID:25143884
Context: Sympathoadrenal response to laryngoscopy and tracheal intubation manifests as transient, but distinct tachycardia and hypertension. Aims: The objective of this study is to compare the clinical effects of dexmedetomidine with esmolol and control in attenuating the presser response during laryngoscopy. Settings and Design: A randomized, prospective, double-blind, controlled study. Subjects and Methods: We studied consented, 90 adult, American Society of Anesthesiologists physical status I and II patients of either sex, scheduled for non-cardiac surgery requiring intubation. The patients were randomly divided into three groups (n = 30). Group C received placebo, Group E received 2.0 mg/kg of esmolol and Group D received 1.0 μg/kg of dexmedetomidine, intravenously over 10 min and 3 min before induction of general anesthesia. All patients were uniformly pre-medicated, induced and intubated using thiopentone and succinylcholine as per standard protocol. Heart rate (HR), systemic arterial pressures were recorded at baseline, after study drug infusion, after induction, immediately and 3, 5, 7, 10 min after intubation. Statistical Analysis: Analysis of variance and t-test as appropriate. Results: The mean arterial pressure was significantly increased in patients receiving placebo (P < 0.0001) and esmolol (P < 0.0001) after laryngoscopy and intubation compared with baseline value and Group D (P = 0.6294). The rise in HR (P = 0.08481) and rate pressure product (P = 0.0666) at the time of intubation were minimal and was statistically significant up to 15 min in Group D. Conclusions: Both the drugs attenuated the pressure response. Of the two drugs administered, dexmedetomidine 1.0 μg/kg provides a consistent, reliable and effective attenuation of pressure responses when compared to esmolol 2.0 mg/kg.
  9 3,589 664
To compare the efficacy and safety of fixed dose combination of thiocolchicoside and aceclofenac versus chlorzoxazone, aceclofenac and paracetamol in patients with acute lower backache associated with muscle spasm
Sanjeev Kumar, Seema Rani, Ramchander Siwach, Prem Verma
July-December 2014, 4(2):101-105
DOI:10.4103/2229-516X.136789  PMID:25143885
Background: The fixed dose combinations (FDCs) of muscle relaxants, non-steroidal anti-inflammatory drugs and paracetamol are commonly prescribed in the treatment of acute lower backache. Aim: The present study was undertaken with the aim of comparing the efficacy and safety of FDCs of thiocolchicoside and aceclofenac versus chlorzoxazone, aceclofenac and paracetamol in patients with acute lower backache associated with muscle spasm. Materials and Methods: A total of 100 patients between ages range from 18 and 55 years having low back pain of ≤7 days duration were randomly divided into two groups. Group A was prescribed thiocolchicoside (4 mg) + aceclofenac (100 mg) while Group B was prescribed chlorzoxazone (500 mg) + aceclofenac (100 mg) + paracetamol (325 mg) orally twice daily for 7 days. Severity of pain at rest and on movement was recorded using visual analogue scale. Muscle spasm was evaluated by hand-to-floor distance and Lasegue's maneuver. Readings were noted on day 1 (baseline), day 3 and day 7. Results: There was statistically significant reduction in severity of pain and muscle spasm on day 3 and day 7 in both groups. There was no statistically significant difference in pain relief and muscle spasm among the treatment groups but clinically showed better improvement in the Group A. The adverse drug reactions occurring during study showed a statistically significant better safety profile in the Group A than Group B . Conclusion: These findings confirm that FDC of thiocolchicoside and aceclofenac is a preferred option for patients with lower backache pain associated with muscle spasm.
  8 10,338 1,130
Frequency distribution of virulence factors in uropathogenic Escherichia coli isolated from Kermanshah in 2011-2012
Parviz Mohajeri, Hosna Khademi, Roya Ebrahimi, Abbas Farahani, Mansour Rezaei
July-December 2014, 4(2):111-116
DOI:10.4103/2229-516X.136794  PMID:25143887
Background: Uropathogenic Escherichia coli (UPEC) can cause urinary tract infection (UTI). To prevent urine flow lavage, UPEC has acquired several virulence factors called adhesins. These adhesins are expressed and controlled by different genes. Aim: This study was aimed to determine some of the most important genes that control virulence factors of UPEC (pyelonephritis associated pili [pap], S fimbrial adhesion [sfa] and A fimbrial adhesion [afa] genes), which code for adhesins and phenotypic factors. Materials and Methods: In total, 205 UPEC isolates from in- and out-patients with UTI were obtained. Polymerase chain reaction was used for gene amplification. One drop of bacterial suspension, one of red blood cells and one of peripheral blood smear were mixed for hemagglutination (HA). Formation of a clump was considered to be positive. Bacteria were grown on blood agar to determine hemolysis. Surface hydrophobicity was determined using the SAT test. Result: Frequencies of pap, afa and sfa were 42 (20.5%), 17 (8.3%) and 44 (21.5%), respectively. Frequencies of HA, hemolysis and hydrophobicity were 138 (67.3%), 56 (27.3%) and 39 (19%), respectively. Among HA-positive bacteria, 103 (74.6%) were mannose resistant. Our results highlight higher frequency of HA than that of other virulence factors, indicating a crucial role of this virulence factor in UPEC. Discussion: We concluded that major differences exist in the prevalence of virulence factors among different UPEC isolated from different countries. The association observed between pathogenicity and virulence factors may promote UPEC survival and growth within the urinary tract. Detecting these genes as the primary controllers of UPEC virulence factors may aid in better management of related infections.
  8 2,871 516
CASE REPORTS
Leiomyosarcoma of the vagina: A rare entity with comprehensive review of the literature
Divya Khosla, Firuza D Patel, Ritesh Kumar, Kiran K Gowda, Raje Nijhawan, Suresh C Sharma
July-December 2014, 4(2):128-130
DOI:10.4103/2229-516X.136806  PMID:25143892
Primary malignant lesions of the vagina are uncommon, and vaginal sarcomas are even rarer. We describe a rare case of stage I, high-grade leiomyosarcoma of the vagina treated with combined modality treatment. A 39-year-old female presented with vaginal mass and underwent resection. Histopathological examination revealed atypical leiomyoma of the vagina with definite risk of recurrence. Eleven months later, she presented with a recurrent vaginal mass and underwent exploratory laparotomy with total abdominal hysterectomy and bilateral salpingo-oophorectomy plus resection of recurrent tumor and partial vaginectomy. The detailed histopathological examination was suggestive of leiomyosarcoma of the vagina. The patient received adjuvant radiotherapy and chemotherapy. The patient is alive and disease-free 29 months postsurgery. Experience with vaginal leiomyosarcomas is limited. The optimal treatment methods have not yet been established because of the rarity of the tumor. We add another case of leiomyosarcoma of the vagina to the limited existing literature.
  7 2,530 310
EDITORIAL
Joint National Committee 8 report: How it differ from JNC 7
Rajiv Mahajan
July-December 2014, 4(2):61-62
DOI:10.4103/2229-516X.136773  PMID:25143876
  7 2,691 460
ORIGINAL ARTICLES
Public knowledge, use and attitude toward multivitamin supplementation: A cross-sectional study among general public
Kavita Sekhri, Kirandeep Kaur
July-December 2014, 4(2):77-80
DOI:10.4103/2229-516X.136780  PMID:25143880
Background and Objective: The use of supplements has increased substantially in the past few decades. The present study is an effort to explore pattern of use, knowledge and attitude toward consumption of multivitamin supplements among the general public. Materials and Methods: A descriptive cross-sectional study on 120 adult participants from the general public was conducted. The participants were interviewed and information was collected in a predesigned structured questionnaire. The data was analyzed and expressed as counts and percentages. Results: Of the 120 study participants, 66 were males and 54 were females. Results revealed that 68.33% (82) of the participants were users of multivitamin supplements. Out of the users, 69.5% (57) participants consumed on the advice of doctors, 18.2% (15) were self-prescribers while 12.1% (10) relied on advice of family or friends. Among the users, 70.96% considered such supplements to be helpful. Reasons quoted for self-medication use of multivitamins were multiple such as maintenance of general health (55%), to allay weakness or fatigue (20%), to improve appetite (15%) etc. Majority of the participants were unaware regarding the correct indications for multivitamin supplementation. Regarding knowledge about the natural sources of these vitamins, as many as 76% showed ignorance. Conclusion: Finding from this study suggests that multivitamin use is highly prevalent and the majority of the participants were ignorant of any possible harm or drug interactions. In light of this, there is a need to adopt certain educational interventions to minimize self-directed supplement use and increase awareness regarding their correct usage.
  6 2,379 489
CASE REPORTS
Low serum iron as a possible risk factor for neuroleptic malignant syndrome
Bhushan Subhash Patil, Alka A Subramanyam, Shipra L Singh, Ravindra M Kamath
July-December 2014, 4(2):117-118
DOI:10.4103/2229-516X.136800  PMID:25143888
Neuroleptic malignant syndrome (NMS) is a rare, but fatal condition characterized by rigidity, fever, dysautonomia and altered consciousness along with elevated serum creatinine phosphokinase levels and leukocytosis. Treatment of NMS includes symptomatic and specific treatment with drugs like bromocriptine may be given. Risk factors for NMS include dehydration, parenteral antipsychotics and high potency antipsychotics. One of the important, but lesser known risk factors for NMS is low serum iron. Pronounced reduction in serum iron suggests that acute phase reactants do have a role in NMS. The present case report focuses on the importance of low serum iron as a risk factor for NMS.
  5 1,813 261
ORIGINAL ARTICLES
Neurolaena lobata L. promotes wound healing in Sprague Dawley rats
Bijoor Shivananda Nayak, Surrin Ramlogan, AV Chalapathi Rao, Sandeep Maharaj
July-December 2014, 4(2):106-110
DOI:10.4103/2229-516X.136791  PMID:25143886
Background: The leaves of the Neurolaena lobata (Asteraceae) plant are used to control diabetes and heal wounds and infections. Aim: The ethanolic extract of N. lobata leaf was evaluated for its ability to heal inflicted wounds in rats using the excision wound model. Materials and Methods: Animals were divided into three groups of six each. Test group animals were treated topically with an ethanolic extract of N. lobata (1:1 with petroleum jelly, 100 mg/kg/day). Standard and control group animals were treated with mupirocin and petroleum jelly, respectively. Treatment was given for 13 days and the wound area was measured on alternate days. Parameters of healing assessed were the rate of wound contraction, period of epithelialization and hydroxyproline content. Antimicrobial activity of the extract was observed against Pseudomonas aeruginosa, Staphylococcus aureus and Escherichia coli. Results: Phytochemical analysis of the extract showed the presence of saponins, tannins, alkaloids and flavanoids. Extract-treated animals exhibited 87% reduction in the wound area over 13 days when compared with the control (78%) and standard (83%) groups (P < 0.05). A significant decrease in the epithelialization period was noticed with the extract-treated test group animals compared with the controls and the standard group animals (P < 0.008). The hydroxyproline content of the extract-treated animals was higher (230.5 ± 42.1) when evaluated against the control and (79.0 ± 32.2) and the standard (115.0 ± 44.5) groups (P < 0.05). Conclusion: Increase in the rate of wound contraction and hydroxyproline content with decrease in epithelialization time in extract-treated animals support further evaluation of N. lobata as a pharmacotherapy for wound healing.
  5 2,830 354
Does short-term exposure to elevated levels of natural gamma radiation in Ramsar cause oxidative stress?
SMJ Mortazavi, A Niroomand-Rad, P Roshan-Shomal, SMT Razavi-Toosi, M Mossayeb-Zadeh, M Moghadam
July-December 2014, 4(2):72-76
DOI:10.4103/2229-516X.136778  PMID:25143879
Background: Ramsar, a city in northern Iran, has areas with some of the highest recorded levels of natural radiation among inhabited areas measured on the earth. Aims: To determine whether short-term exposure to extremely high levels of natural radiation induce oxidative stress. Materials and Methods: In this study, 53 Wistar rats were randomly divided into five groups of 10-12 animals. Animals in the 1 st group were kept for 7 days in an outdoor area with normal background radiation while the 2 nd , 3 rd , 4 th and 5 th groups were kept in four different outdoor areas with naturally elevated levels of gamma radiation in Ramsar. A calibrated RDS-110 survey meter, mounted on a tripod approximately 1 m above the ground, was used to measure exposure rate at each location. On days 7 and 9 blood sampling was performed to assess the serum levels of catalase (CAT) and malondialdehyde (MDA). On day 8, all animals were exposed to a lethal dose of 8 Gy gamma radiations emitted by a Theratron Phoenix (Theratronics, Canada) Cobalt-60 (55 cGy/min) at Radiotherapy Department of Razi Hospital in Rasht, Iran. Results: Findings obtained in this study indicate that high levels of natural radiation cannot induce oxidative stress. CAT and MDA levels in almost all groups were not significantly different (P = 0.69 and P = 0.05, respectively). After exposure to the lethal dose, CAT and MDA levels in all groups were not significantly different (P = 0.054 and P = 0.163, respectively). Conclusions: These findings indicate that short-term exposure to extremely high levels of natural radiation (up to 196 times higher than the normal background) does not induce oxidative stress.
  5 1,921 234
CASE REPORTS
Persistent mullerian duct syndrome: A case report and review of the literature
Vaibhav J Nayak, Akshatha S Kamath, Manjunath Hanumanthappa Krishnappa, Sunil Kumar Bylappa
July-December 2014, 4(2):125-127
DOI:10.4103/2229-516X.136805  PMID:25143891
Persistent mullerian duct syndrome (PMDS) is usually an accidental finding either during orchipexy or during routine inguinal hernia repair in male patients presenting with maldescended or crytorchid testes. It is caused by a defect in the mullerian inhibiting substance system. Intraoperatively, mullerian remnants consisting of an infantile uterus and fallopian tubes are usually found. Familiarity with PMDS is necessary to diagnose the condition. We report a case of PMDS in a 14-year-old male presenting with bilateral undescended testes.
  4 2,020 266
ORIGINAL ARTICLES
Effect of pranayama on rate pressure product in mild hypertensives
Rajni Goyal, Hem Lata, Lily Walia, Manjit K Narula
July-December 2014, 4(2):67-71
DOI:10.4103/2229-516X.136776  PMID:25143878
Context: The modern living life-style is known to produce various physical and psychological stresses resulting in increased blood pressure (BP) and heart rate (HR). This can lead to increased myocardial oxygen demand (MVO 2 ). MVO 2 correlated best with rate pressure product (RPP). RPP is a product of HR and systolic BP. Objective: The present study was conducted to evaluate the effect of relaxation in the form of pranayama on RPP in mild hypertensives. Materials and Methods: Mild hypertensive patients were divided into two groups. Group A received antihypertensive drugs for 6 weeks and Group B received antihypertensive drugs along with pranayama training for 6 weeks. Results: BP decreased significantly in Group B (148 ± 8.09-127 ± 12.10 mm of Hg) where pranayama was added. The decrease was significant as compared to Group A. HR decreased significantly in both the groups as compared to baseline, however the decrease was similar in both groups. RPP decreased significantly in both groups as compared to baseline, however the decrease was significantly more (P < 0.01) when pranayama was added to antihypertensive drugs (96.73 ± 20.53) when compared to antihypertensive drugs alone (114.66 ± 26.30). Conclusion: The pranayama produces relaxed state and in this state parasympathetic activity overrides sympathetic activity. Hence, addition of pranayama can be a useful addition to antihypertensive drugs for better control of hypertension in mild hypertensives.
  4 3,238 558
Modified case based learning: Our experience with a new module for pharmacology undergraduate teaching
Kanchan Gupta, Shalini Arora, Sandeep Kaushal
July-December 2014, 4(2):90-94
DOI:10.4103/2229-516X.136786  PMID:25143883
Objective: The undergraduate teaching in pharmacology has always been a challenging task for medical teachers. Traditional lecture format is monotonous and a passive way of learning. There is a need to shift the educational focus from content centered to case based. In an effort to create interest and further improve the student learning, we have introduced simulated bedside teaching sessions as case based learning (CBL) module (modified CBL-[mCBL]) for 2 nd professional MBBS students. Materials and Methods: A case scenario of a clinical disease condition was prepared in consultation with a clinician. During the session, the case was presented along with discussion on the disease process, its management and rational drug use. Students were encouraged to participate actively. After the session, students were requested to fill the feedback questionnaire anonymously (both open-ended questions and responses on Likert scale). Results: According to the students, factors such as clinical orientation, interactivity and re-enforcement of important points helped them to learn better. Majority of the students (76.09%) found the sessions to be better than theory lectures and tutorials. The fact that the interactive component of departmental feedback (taken at the institutional level) has improved during the last 2 years could be attributed to the introduction of these sessions. Conclusion: mCBL (in the presence of departmental faculty and concerned clinician) is a good method of integrating pharmacology with clinical subjects. To make such sessions more reliable, the next planned step is to assess the knowledge gained by the students during such sessions in the future.
  4 2,502 441
CASE REPORTS
Sacro-coccygeal teratoma in adult: Two rare case reports and review of literature
Narendra Kumar, Divya Khosla, Ritesh Kumar, Uma Nahar Saikia, SK Singh
July-December 2014, 4(2):122-124
DOI:10.4103/2229-516X.136803  PMID:25143890
The sacrococcygeal area is the most common site of extragonadal teratomas in infants, but is a challenge to make clinical as well as radiological diagnosis in adults. We herein describe two cases of sacrococcygeal teratoma (SCT) in adult. The clinical, radiological and histopathological characteristics of both the cases with their outcome are described with review of the literature. The standard care for SCTs is complete surgical resection of the tumor. The presence of malignant transformation is associated with a less favorable outcome.
  3 4,252 291
ORIGINAL ARTICLES
Study of family factors in association with behavior problems amongst children of 6-18 years age group
Sandip S Jogdand, JD Naik
July-December 2014, 4(2):86-89
DOI:10.4103/2229-516X.136783  PMID:25143882
Background: The 'behaviour problems' are having major impact on child's bodily and social development. The family provides emotional support to an individual as well as plays a major role in the formation of one's personality. The quality and nature of the parental nurturance that the child receives will profoundly influence his future development. The knowledge of these family factors associated with behaviour problems may be helpful to identify at risk children. Aims and Objective: To study the family factors associated with behaviour problems amongst children of 6-18 Yrs age group. Setting: an adopted urban slum area of Govt. Medical College, Miraj Dist.Sangli. Design: Cross sectional study. Materials and Methods: the sample size was calculated based upon 40% prevalence obtained in pilot study. Total 600 Children in the age group of 6-18 years residing in the urban slum area and their parents were interviewed with the help of predesigned, pretested proforma. Analysis: chi-square test and risk estimate with Odd's ratio. Results: Our study result reveals significant association between prevalence of behaviour problems with absence of either or both real parents and alcoholism in the parent or care taker. Conclusion: The behaviour problems have good prognosis if they are recognized earlier. Family has great role in prevention of behaviour problems in children, so parental counseling may be helpful.
  3 3,297 380
CASE REPORTS
Neuro-cysticercosis presenting with single delusion: A rare psychiatric manifestation
Suhash Chakraborty, Shilpa R Singi, Gyanaranjan Pradhan, HC Anantha Subramanya
July-December 2014, 4(2):131-133
DOI:10.4103/2229-516X.136808  PMID:25143893
We report a case of multiple parenchymal neurocysticercosis in an elderly lady without raised intracranial tension which caused diagnostic confusion. The initial manifestation was only psychological as delusional disorder without any neurological symptoms or focal neurological deficit. Plain computed tomography scan showed mild bilateral periventricular and subcortical hypodensities. The development of hemiplegia during the course of psychiatric treatment prompted us to go for magnetic resonance imaging brain which clinched the diagnosis.
  1 1,898 277
Recurrent solitary fibrous tumor in distal lower extremity: An extremely rare entity
Shirish S Chandanwale, Charusheela R Gore, Amit B Sammi, Komal R Shah, Parveen R Kaur
July-December 2014, 4(2):134-136
DOI:10.4103/2229-516X.136809  PMID:25143894
Solitary fibrous tumor (SFT) represents a spectrum of mesenchymal tumors, encompassing tumors previously termed hemangiopericytoma, as having intermediate biological potential. Though they can occur at any site, lower distal extremity is a rare site and recurrence in it is extremely rare. Behavior of SFT is unpredictable. Histomorphology and clinical follow-up have poor correlation. The most important single indicator of clinical outcome is complete excision of the tumor at the time of primary presentation. Tumors with positive margins require close follow-up for several years owing to the potential for late local recurrence.
  - 1,537 182
Recurrent ascites with severe hypoproteinemia in 4-year-old child: A diagnostic dilemma - An atypical presentation of hypothyroidism
Sudhir Mehta, Jyoti Sanghvi, Gunjan Kela
July-December 2014, 4(2):119-121
DOI:10.4103/2229-516X.136801  PMID:25143889
Hypothyroidism is frequently encountered condition to a pediatrician. Passive effusions into serous cavities, sometimes to considerable amount are frequently noted. However, the significant ascites caused by this is rare in a child and in no instance, it is too excessive. So diagnosis is frequently delayed and patient frequently receive unnecessary procedures such as liver, even gastrointestinal biopsies. Analysis of ascitic fluid shows exudative nature with high protein. The case we present here is a 4-year-old female child with recurrent ascites, developmental delay and hypoproteinemia. High index of suspicion can lead to diagnosis. Over all prognosis is excellent after stating replacement therapy with L-thyroxine.
  - 3,364 209
ORIGINAL ARTICLES
Female sterilization failure: Review over a decade and its clinicopathological correlation
Shilpa Vishwas Date, Jyoti Rokade, Vidya Mule, Shreedher Dandapannavar
July-December 2014, 4(2):81-85
DOI:10.4103/2229-516X.136781  PMID:25143881
Objectives: The primary objective of the following study is to determine the demographic patterns of women presenting as sterilization-failure and secondary is to evaluate possible etiological factors for failure and lay standard guidelines to reduce failure rate. Materials and Methods: The present study is retrospective study conducted in Department of Obstetrics and Gynecology, Government Medical College and Hospital-based on the case records maintained in our institution over a decade (April 2002-March 2012). Results: Over a decade, 140 cases of sterilization-failure with longest interval of 20 years have been documented out of 80 (57.14%) cases were of minilaparotomy (minilap), 53 (37.86%) laparoscopic tubal ligation and 5 (3.57%) were lower segment cesarean section. In 84 cases (60%) sterilization were performed in Primary Health Centre (PHC). Only 58 (41.43%) patients reported failure in 1 st trimester (<12 weeks). 14 cases (10%) were of ectopic pregnancy. There were 25 cases (17.86%) of spontaneous recanalization. In 27 cases (19.29%) failure was due to improper surgical procedure and rest 54 (38.57%) have conceived due to tuboperitoneal fistula. Conclusion: Female sterilization even though considered as permanent method of contraception, recanalization is possible even 20 years after procedure. Maximum cases of failure were with minilap and those were performed at PHC. The most common cause of failure was tuboperitoneal fistula. Ectopic pregnancies were seen in 10% of cases. Proper counseling of patient is must. There is a need to stick to standards of sterilization procedure to prevent future failure.
  - 5,731 531
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