Evaluation of awareness, acceptability, and clinical outcome of postpartum vaginal insertion and intra-cesarean insertion of intrauterine contraceptive device

Background: Post-placental and intra-cesarean insertion of intrauterine contraceptive devices (PPIUCD) is a lucrative family planning method which provides safe, effective reversible, inexpensive, non-hormonal, and long-acting contraception. Aims and Objectives: The objective of the study is to evaluate the postpartum insertion of intrauterine contraceptive device in terms of awareness, acceptance, safety, efficacy, continuation, and removal rate and its complications in both vaginal as well as intra-cesarean section (CS) insertion. Materials and Methods: Prospective observational study conducted in Obstetrics and Gynaecology Department GMERS sola for 6 months. Two thousand and ninety-four pregnant women from labor room who delivered vaginally or by CS during study period were asked regarding their knowledge and acceptability for PPIUCD. Results: Total 2094 women evaluated for awareness and acceptance for PPIUCD. About 68.66% were familiar with the concept with 29.99% giving verbal consent for its insertion. About 60.01% women refused for various reasons. Conclusion: This study shows that PPIUCD insertion is a safe and convenient method which requires more population awareness, counseling, and usage.

Study of success rate of vaginal birth after cesarean section in relation to FLAMM score

Background: Globally, there is an increased trend of cesarean section (CS). Repeat CS is associated with various complications. Successful vaginal birth after caesarean section (VBAC) helps to decrease CS rate and its associated morbidities. Practice of protocol of applying FLAMM score and monitoring by partogram reduces the rate of cesarean section in the previous one lower segment cesarean section patient. Aims and Objectives: The present study is conducted to evaluate the impact of FLAMM scoring for vaginal birth after CS on obstetrics and perinatal outcome in case of the previous one lower segment CS delivery. Materials and Methods: The prospective and observational study was conducted in Obstetrics and Gynaecology department of one of the teaching institutes of Ahmedabad over a period of 1 year. Total 100 pregnant women from labour room with history of the previous one CS, who gave consent for trial of labor after the previous cesarean (TOLAC) were selected and FLAMM score applied on them. Study participants were divided in two groups according to outcome. Group A: Successful TOLAC and Group B: Failed TOLAC. Maternal and neonatal outcome was measured in both groups. Results: Out of 98 patients <40 years, 74.48% had VBAC and 25% had failed TOLAC and two patients were >40 years of age had VBAC. Out of 94 patients with favorable FLAMM’s score, 79% (n = 75) had VBAC and 100% (n = 6) with unfavorable FLAMM had CS. Conclusion: Careful patient selection for TOLAC is of utmost priority to increase success rate and decrease complications. FLAMM scoring system is a very efficient guiding tool for this. By applying FLAMM score, we increase success rate of TOLAC and thereby decrease CS rate in case of previous CS.

Clinical challenges with excipients in insulin formulations and role of concentrated insulin

Most of the insulin formulations in clinical use contain phenol, meta-cresol or both as excipients. These excipients in insulin preparations provide stability and have antimicrobial properties. However, they are reported to be associated with undesirable side-effects especially localised allergic reactions. Amount of excipients injected per unit dose of insulin is a major determining factor in causation of these reactions. This review discusses the excipients in different insulin formulations available in India with potential of precipitating undesirable effects and the use of concentrated insulins to reduce these complications. To avoid the detrimental effects associated with excipients, removal of preservatives or use of insulin preparations devoid of excipients can be an option. Besides these approaches, one approach that can be considered is the use of concentrated insulin to reduce the volume of insulin dose and thereby the excipients. Concentrated insulins address the high insulin requirements of the growing population of patients with type 2 diabetes who require higher insulin doses. Concentrated insulins help in reduction of dose volume as well as amount of excipients injected per unit dose of insulin. U200 (concentrated r-DNA Human Insulin Premix 30/70-200 IU/ml) can be advantageous with better absorption from smaller quantity injected, lesser variability in absorption, lesser pain and discomfort due to smaller quantity, lesser chances of hypoglycaemia all of which can lead to better patient compliance. Thus, concentrated insulin U200 can be one of the alternatives to prevent/reduce clinical complications with excipients in insulins.

2d And 3d-Qsar Analysis Of Amino (3-((3, 5-Difluoro-4-Methyl-6-Phenoxypyridine-2-Yl) Oxy) Phenyl) Methaniminium Derivatives As Factor Xa Inhibitor

Objective: The main objective of the present study was to evolve a novel pharmacophore of methaniminium derivatives as factor Xa inhibitors by developing best 2D and 3D QSAR models. The models were developed for amino (3-((3, 5-difluoro-4-methyl-6-phenoxypyridine-2-yl) oxy) phenyl) methaniminium derivatives as factor Xa inhibitors. Methods: With the help of Marvin application, 2D structures of thirty compounds of methaniminium derivatives were drawn and consequently converted to 3D structures. 2D QSAR using multiple linear regression (MLR) analysis and PLS regression method was performed with the help of molecular design suite VLife MDS 4.3.3. 3D QSAR analysis was carried out using k-Nearest Neighbour Molecular Field Analysis (k-NN-MFA). Results: The most significant 2D models of methaniminium derivatives calculated squared correlation coefficient value 0.8002 using multiple linear regression (MLR) analysis. Partial Least Square (PLS) regression method was also employed. The results of both the methods were compared. In 2D QSAR model, T_C_O_5, T_2_O_2, s log p, T_2_O_1 and T_2_O_6 descriptors were found significant. The best 3D QSAR model with k-Nearest Neighbour Molecular Field Analysis have predicted q2 value 0.8790, q2_se value 0.0794, pred r2 value 0.9340 and pred_r2 se value 0.0540. The stepwise regression method was employed for anticipating the inhibitory activity of this class of compound. The 3D model demonstrated that hydrophobic, electrostatic and steric descriptors exhibit a crucial role in determining the inhibitory activity of this class of compounds. Conclusion: The developed 2D and 3D QSAR models have shown good r2 and q2 values of 0.8002 and 0.8790 respectively. There is high agreement in inhibitory properties of experimental and predicted values, which suggests that derived QSAR models have good predicting properties. The contour plots of 3D QSAR (k-NN-MFA) method furnish additional information on the relationship between the structure of the compound and their inhibitory activities which can be employed to construct newer potent factor Xa inhibitors.

Utility of Biomarkers in Sepsis: Mirror Reflection of Inner Truculent Devil.

There is a plethora of biomarkers proposed and being researched in the field of sepsis. The complex pathophysiology of sepsis involves many mediators of inflammation pertaining to coagulation, complement, contact system activation, inflammation, apoptosis, etc. Markers related to those processes can gauge the degree of sepsis. Compared with localized pathology, the systemic nature and involvement of multiple organs in sepsis gives scope for numerous potential biomarkers. There is no 'gold standard' for the diagnosis of sepsis. Currently available/in-research biomarkers are compared for their efficacy with methods used to diagnose and monitor sepsis such as combination of clinical signs and available laboratory variables. An arbitrary classification of these biomarkers is made and the literature surrounding these markers and their efficacy in diagnosis of sepsis is reviewed.

IGF-1 and IGFBP 3 in Growth Hormone Deficiency Role of Insulin Like Growth Factor-1 (IGF-1) and IGF Binding Protein 3 in the Diagnosis of Growth Hormone Deficiency: Changing Paradigm.

GH stimulation tests are widely used in the diagnosis of GH deficiency (GHD), although they are associated with a high false positive rate. Serum IGF-I levels are monitored during GH replacement treatment in subjects with GH deficiency (GHD) to guide GH dose adjustment and to minimize occurrence of GHrelated side-effects. The need for reliance on provocative testing is based on evidence that the evaluation of spontaneous growth hormone (GH) secretion over 24 hours and the measurement of IGF-I and IGFBP-3 levels do not distinguish between normal and GHD subjects. Regarding IGF-I, it has been demonstrated that very low levels in patients highly suspected for GHD (i.e., patients with childhood-onset, severe GHD, or with multiple hypopituitarism acquired in adulthood) may be considered definitive evidence for severe GHD obviating the need for provocative tests. However, normal IGF-I levels do not rule out severe GHD and therefore adults suspected for GHD and with normal IGF-I levels must undergo a provocative test of GH secretion. We hereby review the various literatures at disposal justifying the use of IGF-1 and IGBP3 for diagnosis of growth hormone deficiency. Data Source: We searched PUBMED and MEDLINE database for relevant articles including key words. References of each article were further reviewed for final synthesis of the manuscript.

Hirschsprung’s Disease with Congenital Hypothyroidism.

We report a female newborn baby who presented with vomiting and abdominal distension on day 21 of life. Examination revealed facial puffiness, open posterior fontanelles, dry skin, cold peripheries and prominent abdominal veins with visible peristalsis. Barium enema revealed dilated proximal colon, empty rectum, funnel like transition zone between proximal dilated and distal constricted bowel. Serum TSH level was >150 μIU/mL. Biopsy revealed aganglionic segment suggesting Hirschsprung’s disease, an unusual association with congenital hypothyroidism.

Histiocytosis: An Uncommon Presentation with Hypopituitarism.

Langerhans cell histiocytosis is a multi system disorder with a certain predilection for involving hypothalamic pituitary axis. We hereby report a 7 year old girl presenting with polyuria, polydipsia and growth retardation. The girl had a past history of pain in right hip joint and nodular region over chest. Water deprivation test confirmed the diagnosis of central diabetes inspidus. Other investigations revealed Growth hormone deficiency and central hypothyroidism. X-ray and MRI hip revealed absent right inferior pubic ramus with bone marrow biopsy confirming the diagnosis of histiocytosis. Patient was treated with nasal Arginine Vasopressin spray, subcutaneous growth hormone and oral thyroxine.

Precocious Puberty and Pineal Cyst – An Uncommon Association.

We present a five year old boy with central precocious puberty and pineal gland cyst on neuroimaging. This association is uncommon and highlights the role of pineal gland in puberty.

Obesity and thyrotropinemia.

Objective. To study the relation between body mass index (BMI) and TSH in euthyroid and subclinical hypothyroid obese children and compared serum TSH level among obese and overweight children. Methods. Fifty consecutive children (aged 2-18 yr) presenting for obesity were studied. All cases with TSH > 10, low T3/T4, organic and syndromic obesity were excluded. Patients were divided into Group 1: Overweight (n=20) (BMI between 85th to 95th centile) and Group 2: Obesity (n=30) (BMI > 95th centile). Fisher’s exact test, Mann-Whitney U test and Pearson’s correlation were used for statistical analysis. P value < 0.05 was considered significant. Results. Elevated TSH level (between 4.5 – 10 mIU/L) with normal T3, T4 was seen in 4/20 overweight and 9/30 of obese children (P=0.5219). The mean TSH was comparable in both the groups (3.22 ± 3.1 mIU/L vs. 3.63 ± 2.2 mIU/L, P=0.3491). Overall TSH showed no correlation with BMI (r= 0.0014, P=0.9924). Conclusion. The preliminary data did not show any relation between severity of obesity and TSH level. Further large scale data from population are required to confirm these findings.

Symptomatic primary hyperparathyroidism: a retrospective analysis of fifty one cases from a single centre.

OBJECTIVE: Widely prevalent vitamin D deficiency and delayed diagnosis contributes to severe symptomatic primary hyperparathyroidism in India. We analysed fifty one consecutive patients of primary hyperparathyroidism managed at our centre. All of them were symptomatic. DESIGN: Retrospective analysis. MATERIAL AND METHODS: Fifty one consecutive cases of symptomatic primary hyperparathyroidism, presenting to our centre from January 1994 to May 2007 were retrospectively analyzed. Clinical presentation, biochemical, radiological and details of underlying parathyroid lesion were noted. RESULTS: A total of 51 cases of primary hyperparathyroidism were studied. Mean age was 39.5 +/- 11.5 yrs (Range 13 to 70 years, Female: Male 2:1). Mean duration of symptoms was 35.8 + 29.1 months. Bone pains and painful proximal myopathy were the commonest presentation (24/51), followed by pathological fractures in 12 cases. Distal Renal tubular acidosis was diagnosed in 4 cases, 3 of whom normalized after surgery. At initial evaluation, twenty one patients had elevated alkaline phosphatase with normal calcium levels indirectly suggesting associated vitamin D deficiency. Low serum levels of 25-hydroxy vitamin D were documented in five of them. Parathyroid carcinoma was diagnosed in 3 patients. Ectopic parathyroid adenoma was seen in 7 cases (3 mediastinal, 3 intrathyroidal, 1 near left carotid sheath). All the cases responded well to surgical excision. CONCLUSION: Lack of universal screening for hypercalcemia, normocalcemia contributed by associated vitamin D deficiency and lack of awareness about unusual presentations of primary hyperparathyroidism led to delayed diagnosis in our patients. Delayed diagnosis and associated vitamin D deficiency in our patients contributed to greater severity of symptomatic primary hyperparathyroidism.

Efficacy of teriparatide in increasing bone mineral density in postmenopausal women with osteoporosis--an Indian experience.

BACKGROUND AND OBJECTIVE: Osteoporosis is emerging as a leading cause of substantial morbidity in India, particularly in postmenopausal women. Teriparatide (recombinant human parathyroid hormone [1-34]) increases bone formation and improves bone microarchitecture, thereby reducing the risk of fractures. This study was conducted to evaluate the efficacy of teriparatide in increasing bone mineral density (BMD) in postmenopausal women with osteoporosis. MATERIAL AND METHODS: A randomised, prospective, multicentre, open-label, controlled study was conducted on 82 postmenopausal women with established osteoporosis. Patients were randomly divided into control and teriparatide groups, each group consisting of 41 patients. All the patients were supplemented with 1000 mg of elemental calcium and 500 IU of vitamin D throughout the study period of 180 days. Besides, teriparatide group patients were administered teriparatide 20 microg daily subcutaneously. Lumbar spine, femoral neck and total hip BMD, bone mineral content (BMC) and bone area were measured by dual energy x-ray absorptiometry (DXA) at baseline and at the end of 6 months of treatment. Bone biomarkers, such as serum bone specific alkaline phosphatase (BSAP) and serum osteocalcin (OC), representing bone formation, and urinary deoxypyridinoline (DPD), representing bone resorption were assessed at baseline, and at 3 and 6 months of treatment. RESULTS: During the study period, 9 patients (11%) were lost to follow-up--6 in control group (7.3%) and 3 in teriparatide group (3.7%). There was an excellent compliance to both oral and injectable medication. The investigational product teriparatide was well tolerated and there were no serious adverse events. In addition, there were no significant differences between the groups in the incidence of adverse events. The percentage of increase in lumbar spine BMD, which is the primary endpoint, was significantly (P < 0.001) higher in teriparatide group compared to that in control group (6.58% vs. 1.06%). Further, teriparatide significantly increased percentage of change in lumbar spine T-score (P < 0.001), BMC (P < 0.001) and bone area (P < 0.028) compared to control group at 6 months. Administration of teriparatide resulted in a significant percentage of increase in all the bone biomarkers in teriparatide group compared to control group patients at 3 and 6 months over baseline, thereby showing that there was a significant increase in bone turnover in teriparatide group of patients. CONCLUSION: These results show that teriparatide is an effective and safe drug in increasing the BMD and therefore, teriparatide provides yet another new therapeutic option for reducing the risk management of osteoporosis in postmenopausal women (clinicaltrials.gov number, NCT00500409).

Ectopic parathyroid adenoma--the hidden culprit.

Primary Hyperparathyroidism is known to present with protean manifestations leading to misdiagnosis in the initial stages of the disease. Inability to locate the adenoma in an ectopic parathyroid gland may further delay the diagnosis of these cases. Aberrant migration during development may lead to intrathyroidal or other ectopic locations of parathyroid glands. This may lead to their misdiagnosis as a thyroid nodule or failure to locate parathyroids during surgery. Similarity in cytological picture between thyroids and parathyroids may further complicate diagnosis by fine needle aspiration cytology. Nuclear imaging scintigraphy accurately localizes the tumor in 90% of cases and simplifies the surgical management. We encountered three such cases with the parathyroid gland adenomas in ectopic locations in which pre-operative nuclear imaging played a major role.

Growth hormone-producing pituitary tumours: clinical profile and results of surgery.

BACKGROUND: Growth hormone-producing pituitary tumours present with a wide variety of manifestations. The optimum diagnostic work up, management and follow up of such patients is complex and involves a multidisciplinary approach. There is paucity of data from India with regard to the clinical presentation and results of surgery for growth hormone-producing tumours. METHODS: We studied the first 50 patients presenting during 1989-94 with growth hormone-producing pituitary tumours to our centre. The work up included detailed endocrine and radiological assessment. The surgical outcome was analysed for 35 patients who were operated (trans-sphenoidal 29, transcranial 6) at our centre. RESULTS: All the patients had macroadenomas [mean (SD) diameter 3.12 (0.87) cm]. Seventy-five per cent of the patients had supra- and/or parasellar extension and 57% had visual field defects. Tumour size correlated with the preoperative basal (r = 0.57) and glucose-suppressed (r = 0.54) growth hormone levels. Thirty-three of the 35 patients operated at our centre (trans-sphenoidal 28, transcranial 5) were available for follow up (median duration 34 months). After trans-sphenoidal surgery alone, 12 of the 28 (43%) patients had normalization of growth hormone levels (post-glucose growth hormone < 5 ng/ml), and 9 of 11 (82%) showed improvement in visual fields. CONCLUSION: In India, growth hormone-producing pituitary tumours are usually large in size. The growth hormone levels correlate with the size of the tumour. These tumours can be effectively treated by trans-sphenoidal or transcranial surgery.

Renal involvement in leprosy.

Renal involvement was studied in 70 patients with leprosy by urine analysis, detailed biochemical investigations and renal histopathology. Of these 70 patients, 40 had lepromatous and 30 had non-lepromatous leprosy. Creatinine clearance was reduced in 20 patients. Renal biopsies were studied in 50 cases (25 lepromatous, 25 non-lepromatous); of which in 13 cases (10 lepromatous, 3 non-lepromatous) abnormal histopathological lesions were found by light microscopy. Amyloidosis was seen in only one lepromatous patient. No acid-fast bacilli and leproma like lesion were demonstrated in any case.