Diagnostic Accuracy of Diabetes in Pregnancy Study Group of India with Carpenter-Coustan and National Diabetes Data Group Criteria for Diagnosis of Gestational Diabetes Mellitus and Correlation with Fetomaternal Outcome.

Background: No previous study compared ACOG and DIPSI criteria for diagnosing gestational diabetes (GDM). This study compared diagnostic accuracy of Diabetes in pregnancy study group of India (DIPSI) with Carpenter-Coustan (CC) and National Diabetes Data Group (NDDG) criteria for diagnosis of GDM and correlation with fetomaternal outcome. Methods: A total of 1029 pregnant women underwent 2 h 75 g OGTT in non-fasting state. After 3-7 days, women were called in fasting state and subjected to 100 g OGTT and fasting, 1, 2, 3 h samples were taken. GDM was diagnosed using DIPSI, CC and NDDG criteria. All women were followed till delivery, and fetomaternal outcome was noted. Results: 10.4% (107) women were diagnosed as GDM by DIPSI, 6.4% (66) by CC and 3.1% (32) by NDDG criteria. Sensitivity of DIPSI with CC was 98.48%, specificity was 95.64%, and diagnostic accuracy was 95.82%. Sensitivity of DIPSI with NDDG was 99.89%, specificity was 92.38%, and diagnostic accuracy was 95.52%. Sensitivity of NDDG with CC was 48.48%, specificity was 100%, and diagnostic accuracy was 96.7%. Women with GDM by all three criteria were seen to have a significantly higher proportion of LSCS, higher birth weight and macrosomia compared to normoglycemic women (p value < 0.001). Conclusion: Diagnostic accuracy, sensitivity and specificity of DIPSI are comparable to CC and NDDG criteria; therefore, DIPSI can be recommended for diagnosing GDM with added advantage of low cost, simplicity and convenience. Women diagnosed as GDM by DIPSI, CC and NDDG had significantly higher rate of cesarean delivery, higher birth weight and macrosomia as compared to women with normoglycemia.

Can Seminal IL-8 Level Be Used as a Marker of Leukocytospermia and Does It Have Any Correlation with Semen Parameters in Infertile Couples?

OBJECTIVES: Infection of male genital tract leads to leukocytospermia which may have a detrimental effect on semen quality. This study was conducted to evaluate whether seminal IL-8 level can be used as a marker of leukocytospermia and does it have any correlation with semen parameters in infertile couples? METHODS: This cross-sectional study was conducted in an infertility clinic of a tertiary care hospital including 150 male partners of infertile couples who underwent semen analysis (WHO laboratory manual for the examination and processing of human semen, 5th edn, World Health Organization, Geneva, p 271, 2010), semen culture sensitivity and seminal IL-8 levels. Independent t-test, Mann-Whitney U test and Chi-square test were applied for analysis. RESULTS: Mean seminal plasma IL-8 level of patients with leukocytospermia was significantly higher than patients without leukocytospermia (1143.67 ± 887.03 vs. 267.174 ± 242.29, p value < 0.001). Strong positive correlation was found between seminal plasma IL-8 levels and pus cells in the semen (r = 0.950, p < 0.001); AUC for seminal plasma IL-8 was 0.985 (CI 0.972-0.988), and a cutoff value of 399 pg/ml was determined to diagnose leukocytospermia. This value had high sensitivity (91.8%), specificity (94.5%), positive predictive value (94.4%) and diagnostic accuracy (93.2%) for detecting leukocytospermia. Seminal IL-8 levels correlated negatively with sperm motility (r = - 0.29, p < 0.001) and morphology (r = - 0.230, p < 0.01). CONCLUSION: Seminal plasma IL-8 levels were found to be almost five times higher in male partners with leukocytospermia than in non-leukocytospermia group, and it appears to be a promising tool to detect leukocytospermia. Seminal IL-8 level correlated negatively with semen parameters including sperm motility and morphology.

Prenatal Yoga: Effects on Alleviation of Labor Pain and Birth Outcomes.

Background: This study was conducted to test the hypothesis that prenatal yogic exercises are effective in alleviating labor pain and improving birth outcomes, by comparing pregnant women undertaking yoga with a control group. Trial design: Single blinded, parallel randomized control trial. Methods: Two hundred primigravid women of 30 weeks of gestation onward who met the inclusion criteria (primigravida, 20-35 years of age, gestational age of 30 weeks, no prior experience of yoga) were randomly assigned to study (n = 100) and control groups (n = 100) by using the minimized randomization program version 2.01. The study group received the intervention in the form of integrated yoga consisting of a series of 30-min practice sessions at the 30th, 32nd, 34th, 36th, 37th, 38th, and 39th weeks of gestational age. The matched control group did not perform yoga. The patients were followed till delivery for maternal comfort, alleviation of labor pain, and birth outcome. Alleviation of labor pain was assessed by using numerical pain intensity scale (NPIS), pain behavioral observational scale (PBOS), and maternal delivery comfort questionnaire. Only the assessors were blinded. Results: Two hundred patients were randomized into 100 each in case and control groups. Final analysis was done on 75 patients in each group after exclusion due to development of complications, loss to follow-up. The requirement of induction of labor and analgesics was significantly less in the study group (p < 0.044, p < 0.045). There was significantly more number of normal vaginal deliveries (p < 0.037) and less caesarean sections (p < 0.048), shorter first stage of labor (p < 0.0003) in the study group practicing yoga. The tolerance of pain was better in the study group as shown by NPIS (p < 0.001) and PBOS scores (p < 0.0001). Postpartum, the maternal comfort questionnaire score showed higher comfort in the study group (p < 0.032). The number of low birth weight babies was also significantly less in the study group (p < 0.042). There were no adverse effects attributed to yoga. Conclusion: The study has highlighted that yoga is a noninvasive, easy to learn mind-body medicine and complementary health practice, effective in alleviation of labor pain and possibly improving birth outcome.

Evaluation of serum Glutathione-S Transferase-Alpha as a Biomarker of Intrahepatic Cholestasis of Pregnancy.

OBJECTIVE: To evaluate if serum Glutathione-S Transferase-Alpha (GSTA) can be used as a biomarker of intrahepatic cholestasis of pregnancy (IHCP). METHODS: 45 pregnant women with IHCP and 45 age and weight matched pregnant women as controls were enrolled and liver function tests including serum GSTA were measured. All cases and controls were followed for their maternal and foetal outcomes till delivery. Statistical analysis included unpaired t test, Mann-Whitney test and chi square test. RESULTS: IHCP group showed higher mean serum GSTA concentrations compared to controls (85.6 ± 42.7 mcg/l vs. 40.6 ± 6.8 mcg/l; p < 0.001, CI 95%). A positive correlation was observed between serum GSTA and other markers of IHCP like serum bilirubin (r=0.346; p< 0.001), AST (r=0.708; p< 0.001), ALT (r=0.656; p< 0.001) and bile acids (r= 0.491; p< 0.001).Cut off value for GSTA of 47 mcg/l demonstrated good sensitivity (97.8%),specificity (88.9%), positive predictive value (89.8%) and accuracy (93.3%) to diagnose IHCP. CONCLUSION: Serum GSTA may be a new promising, diagnostic tool with good accuracy compared to the routine markers for diagnosing IHCP.

Comparison of Diagnostic Accuracy of Non-fasting DIPSI and HbA1c with Fasting WHO Criteria for Diagnosis of Gestational Diabetes Mellitus.

BACKGROUND: To compare diagnostic accuracy of non-fasting DIPSI and HbA1c with fasting WHO 1999 as gold standard for diagnosis of gestational diabetes mellitus (GDM). METHODS: Pregnant women attending antenatal clinic underwent a 2-h 75-gm GCT in non-fasting state (DIPSI). HbA1c was also determined at the same sitting. A 2-h 75-gm GCT was repeated for all women after 72 h in a fasting state (WHO criteria). GDM was diagnosed if plasma glucose was ≥140 mg/dl by either test or if HbA1C ≥6%. RESULTS: Of the 800 women evaluated, 51 were diagnosed as GDM by WHO criteria, 63 by DIPSI, and 40 by HbA1c. The sensitivity of DIPSI test with respect to WHO 1999 was 98.04% and specificity 98.26%. The diagnostic accuracy was 98.25%. The area under the ROC curve for DIPSI was 0.988 (p < 0.001) (95% confidence interval: 0.960-1.000). The sensitivity of HbA1c with respect to WHO GTT was 47.06%, specificity 97.86%, and diagnostic accuracy 94.63%. The ROC curve between WHO GTT and HbA1c covered an area of 0.805 (p < 0.01) (95% confidence interval: 0.731-0.879). CONCLUSIONS: Non-fasting DIPSI criteria had high diagnostic accuracy compared to gold-standard WHO GTT and can be an effective and practical alternative to the latter. HbA1c had a low sensitivity although the specificity was good and therefore is not a suitable test for screening GDM.

Association of IL-1ß, IL-1Ra and FABP1 gene polymorphisms with the metabolic features of polycystic ovary syndrome.

BACKGROUND: Polycystic ovary syndrome (PCOS), a highly prevalent endocrinopathy is currently being designated as chronic low grade inflammatory state. IL-1ß, IL-1Ra and FABP1 are critical mediators of inflammatory processes and are speculated to play a role in the pathogenesis of PCOS. The aim of this study was to study the association of IL-ß, IL-1Ra and FABP1 gene polymorphisms with PCOS and related metabolic features. SUBJECTS: 95 PCOS and 45 age matched healthy control subjects were enrolled in this study. METHODS: Polymorphism in genes IL-1ß, IL-1Ra and FABP1 was studied by PCR, PCR-RFLP and sequencing methods, respectively. Hormonal and lipid profiles were evaluated for all the subjects. RESULTS: Hormonal and lipid profiles showed significant differences between PCOS and control subjects. Allele and genotype frequencies of IL-1ß, IL-1Ra and FABP1 gene polymorphisms did not vary between the control and PCOS group. However, T allele of C[-511]T variant of IL-1ß, allele II in intron 2 of IL-1Ra and A allele of A/G variant of FABP1 (rs2197076) showed significant association with many metabolic features associated with PCOS. CONCLUSIONS: Polymorphism in genes encoding cytokines and proteins involved in lipid metabolism can provide insights into the genetics of the disease and may contribute to assess the associated risk of cardiovascular diseases (CVD), dyslipidemia and metabolic syndrome (MetS) associated with PCOS.

Evaluation of Pharmacists' Services for Dispensing Emergency Contraceptive Pills in Delhi, India: A Mystery Shopper Study.

BACKGROUND: Although emergency contraceptive pills are available over the counter, the quality of consultation, including key areas of contraceptive counseling and prevention of sexually transmitted infections (STI), has not been well documented. OBJECTIVE: To evaluate actual pharmacist services while dispensing emergency contraception through a mystery shopper technique. MATERIAL AND METHODS: This cross-sectional study was conducted in 81 pharmacies situated in Delhi by 4 trained mystery shoppers posed as customers over a period of 6 months. RESULTS: None of the pharmacists asked about the time lapsed since last unprotected sexual intercourse or last menstrual period before deciding the eligibility of the customer. The majority were unclear about side effects associated with emergency contraception (78.57%) or with anticipated changes in menstrual flow (78.57%); 85.71% did not know whether subsequent unprotected intercourse would be protected. Only 15.71% counseled shoppers regarding risk of STI on asking leading questions and 88.5% did not provide any contraceptive advice. CONCLUSION: There is a huge gap in the technical knowledge and mindset of the pharmacists when it comes to checking for the eligibility of the client and providing advice regarding use of regular contraception and barrier for protection from STI, which needs to be addressed in order to realize the full benefit of making emergency contraceptive pills available over the counter.

HPV Vaccination in India: Critical Appraisal.

Cervical cancer is the third most common cancer in women worldwide. The role of human papilloma virus (HPV) in the genesis of cervical carcinoma is well documented. The HPV 16 and 18 are found to be most commonly associated with invasive cervical carcinoma. The advent of cervical carcinoma vaccine has advanced the hopes that eradication of cervical carcinoma might be possible in future. The scenario of prevention of cervical carcinoma is completely different in developed and developing countries. The implementation of the vaccination as a routine in India is still controversial. Here we have tried to critically analyse these issues in Indian context. However it is clear that cervical cancer vaccine is not an immediate panacea and cannot replace the cervical cancer screening which is mandatory in Indian context.

Acardiac anceps: a rare congenital anomaly.

Acardiac twin is a rare congenital anomaly and is exclusively associated with monochorionic twin pregnancies. The abnormalities occur due to abnormal communication between the two fetuses in the form of arterioarterial and venovenous communications, resulting in a grossly abnormal acardiac twin with reduction anomalies mainly of the upper body and gross oedema. Since no two acardiac twins are alike, this case report will add to the acardiac twin anomaly spectrum.

Over-the-Counter Sale of Emergency Contraception: A Survey of Pharmacists in Delhi.

INTRODUCTION: Pharmacists play a key role while dispensing over-the-counter emergency contraception (EC) to the client. AIMS: The study aims to evaluate the knowledge and over-the-counter services provided by the pharmacists in Delhi. METHODS: A prestructured questionnaire-based survey was conducted in Delhi, the capital city of India. RESULTS: Only 60 out of 85 pharmacies approached agreed to participate in the study. Number of packs sold in a month per pharmacy varied from 2 to 500 packs/month. Sixty-two percent of the pharmacists claimed that majority of the clients repeated use during the same month. Only 18% of the clients were referred by doctors while 82% directly approached the pharmacists. Nearly one third of the clients were adolescents. Sixty-seven percent of the pharmacists had adequate knowledge about EC. Only 3.3% asked about the last menstrual period or the time elapsed since the last unprotected intercourse. No pharmacist inquired whether there were one or multiple unprotected acts of intercourse, if any regular contraceptive method was being used, or explored the reason for EC intake. There were 91.7% who explained the dosage schedule to clients. Only half of them explained that the client may experience side effects. None of the pharmacists advised their clients for a sexually transmitted disease screening, and 35% counseled the clients regarding regular contraception. CONCLUSION: Improving the quality of services provided by the pharmacists can clear misconceptions of the clients and promote subsequent regular contraception along with precautions to avoid sexually transmitted diseases. Mishra A and Saxena P. Over-the-counter sale of emergency contraception: A survey of pharmacists in Delhi. Sex Med 2013;1:16-20.

Polycystic ovary syndrome: Is obesity a sine qua non? A clinical, hormonal, and metabolic assessment in relation to body mass index.

OBJECTIVE: To determine the proportion of polycystic ovarian syndrome (PCOS) patients who have normal body mass index (BMI) and to compare the clinical, hormonal, and metabolic profile between lean and overweight patients of PCOS. MATERIALS AND METHODS: One hundred consecutive infertile women with PCOS were studied and divided into lean (BMI between 18.5 and 23) and overweight (BMI ≥ 23). Metabolic and hormonal profile (serum FSH, LH, testosterone, prolactin, TSH on days 2-3 of menstrual cycle; serum progesterone premenstrually; serum insulin-fasting and 2 hours postglucose, glucose tolerance test, and fasting serum lipid profile) was performed along with pelvic sonogropahy; and clinical features, viz. waist hip ratio, hirsutism, acne, acanthosis nigricans, and clitoromegaly were recorded. RESULTS: 42% of the PCOS subjects had normal BMI. Average age, hirsutism (80.9% vs. 89.7%), irregular cycles (92.8% vs. 96.6%), acne (9.5% vs. 15.5%), clitoromegaly (2.3% vs. 3.4%), endometrial thickness >4 mm (9.5% vs. 15.5%), and hormonal profile were similar in the lean and overweight PCOS groups. Family history of diabetes (9.5% vs. 24.1%), abnormal glucose tolerance test (GTT) (4.7% vs. 10.3%), deranged lipid profile (14.2% vs. 31%), and 2-hour postprandial insulin levels were higher in the overweight PCOS (P < 0.05). Insulin resistance was observed in 83.3% of lean PCOS but was still lower than 93.1% seen in overweight PCOS (P < 0.05). CONCLUSION: 42% of the PCOS had normal BMI, but clinical and hormonal profile was similar to PCOS patients with elevated BMI (overweight/obese). However, insulin resistance is observed in 83.3% of lean PCOS. Family history of diabetes, impaired GTT, deranged lipid profile, and insulin resistance were more prevalent in overweight PCOS.

Surrogacy: ethical and legal issues.

Surrogacy refers to a contract in which a woman carries a pregnancy "for" another couple. Number of infertile couples from all over the World approach India where commercial surrogacy is legal. Although this arrangement appears to be beneficial for all parties concerned,there are certain delicate issues which need to be addressed through carefully framed laws in order to protect the rights of the surrogate mother and the intended parents.

Pregnancy outcome of women with gestational diabetes in a tertiary level hospital of north India.

BACKGROUND: Women with gestational diabetes mellitus (GDM) pose an important public health problem because diabetes not only affects the maternal and fetal outcome, but these women and their fetuses are also at an increased risk of developing diabetes and related complications later in their life. OBJECTIVES: The study was conducted to determine the maternal and fetal outcomes of 50 diabetic vs 50 normoglycemic pregnancies. MATERIALS AND METHODS: This was a retrospective analytical record-based study conducted in a tertiary level hospital. Detailed information regarding maternal, fetal, and labor outcome parameters was recorded in a prestructured proforma and compared in normoglycemic and diabetic pregnancies. RESULTS: Patients with obesity, history of diabetes in the family, spontaneous abortions, and gestational diabetes in previous pregnancies had a greater incidence of GDM in current pregnancy (P<0.05 for all). Hypertension, polyhydramnios, macrosomia, fetopelvic disproportion, and cesarean sections were more (P<0.001) among diabetic pregnancies. Congenital anomalies, polycythemia, hypocalcemia, and hyperbilirubinemia were also observed to be more (P<0.05) in neonates born to diabetics, suggesting an adverse effect of hyperglycemia in utero. CONCLUSION: Diabetes during pregnancy is associated with higher maternal and fetal morbidity. Therefore, early screening, detection, close monitoring, and intervention is essential to reduce maternal and fetal short- and long-term adverse effects, especially in high-risk groups. Pregnancy provides an opportunity to the clinician to control the disease process and inculcate healthy lifestyle practices in these patients.

Efficacy of 2-hour post glucose insulin levels in predicting insulin resistance in polycystic ovarian syndrome with infertility.

BACKGROUND: Insulin resistance (IR) is central to the pathogenesis of polycystic ovarian syndrome (PCOS), but tests for determining IR are elaborate, tedious and expensive. AIMS: To evaluate if "2-hour post-glucose insulin level" is an effective indicator of IR and can aid in diagnosing IR in infertile PCOS women. SETTINGS AND DESIGN: Observational study at infertility clinic of a tertiary care center. MATERIALS AND METHODS: 50 infertile women with PCOS and 20 females with tubal/male factor infertility were evaluated for the presence of IR, as defined by the fasting/2-hour post-glucose insulin levels cutoffs of >25/>41 µU/mL, respectively. The clinical, metabolic and endocrinologic profile was determined in both the groups. STATISTICAL ANALYSIS: Statistical analysis was performed using SPSS (Chicago, IL, USA). RESULTS: Body mass index, post load glucose, insulin, glucose/insulin ratio, area under curve (AUC) of glucose and insulin and insulinogenic index were significantly lower in the controls as compared to the PCOS group. "2-hour post-glucose insulin levels" were elevated in 88% of PCOS individuals but were normal in all females not suffering from PCOS. These levels significantly correlated with AUC of glucose and insulin, and insulinogenic index and inversely correlated with 2-hour glucose to insulin ratio (r=0.827, 0.749 and -0.732, respectively). CONCLUSIONS: "2-hour post-glucose insulin levels" appears to be a good indicator of IR. It can be a useful tool, especially in low resource setting where a single sample can confirm the diagnosis, thus reducing cost and repeat visits.

Effect of metformin therapy on 2-h post-glucose insulin levels in patients of polycystic ovarian syndrome.

AIMS: To evaluate if 2-h post glucose insulin level is an effective tool to monitor insulin resistance in response to metformin therapy, in infertile women with polycystic ovarian syndrome (PCOS). SETTINGS AND DESIGN: This prospective observational study was carried out in a tertiary care infertility clinic. MATERIALS AND METHODS: 40 women with PCOS were categorized as having insulin resistance if fasting or 2-h post glucose insulin levels were >25 or >41µU/ml respectively. Post glucose insulin was compared before and after six months of metformin therapy along with other clinical, hormonal and metabolic parameters by using McNemar and the Student's t-test. RESULTS: Fasting insulin was elevated in 4 (10%) and post-load insulin in 34 (85%) patients; after metformin therapy respective values were 2 (5%) and 16 (40%). Metformin therapy reduced post glucose insulin levels (P<0.001), improved the regularity of periods (P<0.001) and resulted in reduction of LH levels (P<0.001), total testosterone (P<0.001) and mean Body mass index (BMI) (P=0.047). Metformin therapy did not alter waist-hip ratio and fasting insulin levels. CONCLUSION: 2-h post glucose insulin level is an effective tool to monitor insulin resistance in PCOS patients and improves significantly after metformin therapy, similar to improvements observed in clinical, hormonal and metabolic parameters.

A randomised comparison between sublingual, oral and vaginal route of misoprostol for pre-abortion cervical ripening in first-trimester pregnancy termination under local anaesthesia.

OBJECTIVE: To compare efficacy of sublingual (S/L), oral and vaginal routes of misoprostol administration for cervical priming before suction evacuation (SE) under local anaesthesia. METHODS: In a prospective randomised clinical trial, 200 women in the first trimester of pregnancy were randomised into four groups of 50 each. Patients in control group did not receive any medication before SE while other treatment groups received 400 microg of misoprostol three hours prior to SE either by sublingual/oral or by vaginal route. Main outcome measure was basal cervical dilatation while the secondary outcome measures were operative blood loss, time duration of surgery, patient satisfaction, pain perception and adverse effects. RESULTS: Sublingual group had a higher dilatation (9.9 +/- 2.1 mm; P < 0.001) and lower time duration of surgery (3.6 +/- 1.0 min; P < 0.01) as compared to oral (8.2 +/- 2.6 mm, 4.9 +/- 1.7 min) or vaginal routes (7.6 +/- 2.6 mm, 5.2 +/- 1.8 min). Mean pain score of the sublingual group was significantly lower (2.4 + 1.3; P < 0.001) as compared to oral (3.4 +/- 1.3) or vaginal routes (3.6 +/- 1.2). Patient acceptability was higher for sublingual (53 of 150) and oral routes (62 of 150) as compared to vaginal (35 of 150) route. CONCLUSION: Sublingual route was significantly more effective than oral or vaginal administration of misoprostol for cervical dilatation. To the best of our knowledge, this is the first study to simultaneously compare the efficacy of sublingual, oral and vaginal routes of misoprostol for cervical priming before SE.

Is abnormal sperm function an indicator among couples with recurrent pregnancy loss?

OBJECTIVE: To determine whether or not sperm function parameters are altered in male partners of couples with a history of idiopathic recurrent pregnancy loss (RPL). DESIGN: In comparison with proven fertile volunteers, sperm function parameters like hypo-osmotic swelling (HOS), acrosomal status (AS), and nuclear chromatin decondensation (NCD) were assessed in vitro from male partners of couples with a history of idiopathic RPL. SETTING: Infertility clinic and andrology laboratory at National Institute of Health and Family Welfare. PATIENT(S): Male partners of couples with a history of idiopathic RPL and proven fertile male volunteers (control). INTERVENTION(S): Standard semen analysis, assessment of sperm morphology, and sperm function with tests such as HOS, AS, and NCD. MAIN OUTCOME MEASURE(S): Sperm paameters, such as HOS, AS, and NCD, were assessed in semen samples from RPL in comparison with the proven fertile control group. RESULT(S): Semen samples from the idiopathic RPL group showed below normal test scores in 57.1% of the cases for all three sperm parameters. The highest aberration (83% of cases) in sperm attributes was observed in NCD, followed by AS (45.7%) and HOS (42.9%). In contrast, abnormality in sperm morphology was limited to 5.7% of the cases. Subnormal sperm function is directly proportional with subnormal sperm motility (<50%) in 23% of the cases. Even in semen samples with normal sperm motility, sperm function scores were below normal in 31.4% of the RPL group. CONCLUSION(S): Reduction in test scores of sperm function, like HOS, AS, and NCD, in male partners of couples with idiopathic RPL suggests that sperms with altered or lowered functional competencies, if they fertilize the oocytes, may lead to the development of an unsustainable embryo resulting in early pregnancy loss. Normal sperm motility does not always ensure normal sperm function scores.