Prevalence of gestational diabetes mellitus and perinatal outcome: a rural tertiary teaching hospital based study

Background: Gestational diabetes mellitus is the commonest medical disorder in pregnancy. Women with GDM are at increased risk for adverse obstetric and perinatal outcome. Prevalence of GDM is known to vary widely depending on region of the country, dietary habits and socio-economic status. This study was undertaken to evaluate the prevalence of GDM and risk factors associated with it among women delivered in a rural tertiary teaching hospital in Telangana and further assess its impact on feto-maternal outcome.Methods: A retrospective study was conducted at Mediciti Institute of Medical Sciences on GDM cases delivered from May 2015 to April 2017. GDM was diagnosed using 2 step procedure of screening with glucose challenge test followed by confirmation with oral glucose tolerance test using Carpenter and Couston criteria. Demographic data and details about perinatal outcome were obtained from medical records and analyzed.Results: The prevalence was low (1.83%) compared to other studies. Majority of the women did not have risk factors. Preeclampsia is the commonest maternal complication seen (18%). Hypothyroidism is more often associated with GDM (15%). Caesarean section rate was high (62%). Though the NICU admission rate was high (76%), neonatal outcome was found to be satisfactory.Conclusions: The low prevalence of GDM seen highlights the importance of carrying out studies in different population groups of India to know the exact prevalence of GDM in the country. Pregnancies in women with GDM continue to be at increased risk of maternal and perinatal complications

Prevalence and determinants of caesarean section in a rural tertiary teaching hospital: a 6-year retrospective study

Background: Caesarean section is the most commonly performed surgery in obstetrics and there is a rise in caesarean section rates in recent times. This study was undertaken to know the changing trends in caesarean section rate in a rural hospital and to examine the indications contributing to it. The objective of the present study was to know the prevalence and changing trends in caesarean section over the last 6 years (April 2012-March 2018).Methods: Demographic data for all the deliveries, mode of delivery and indications of caesarean sections performed from April 2012 to March 2018 that occurred at MIMS were collected in a retrospective manner.Results: Among a total of 12,522 women delivered during the study period of 6 years, 44.93%, 48.49%, 48.41%, 50.9%, 45.48% and 49.62% were delivered by caesarean section during 2012-2013, 2013-2014, 2014-2015, 2015-2016, 2016-2017 and 2017-2018 respectively. Increase in repeat caesarean section is the primary reason for these increased rates followed by fetal distress. There is a rise in the repeat caesarean section from 44.36% in 2012-2013 to 55.67% in 2016-2017 and 47% in 2017-2018. Whereas primary caesarean section rate reduced from 55.63% in 2012-2013 to 44.32% in 2016-2017 and 53% in 2017-2018.Conclusions: As repeat caesarean section and fetal distress are the most common causes of caesarean section we need to address these to bring down the caesarean section rate

Prevalence of teenage pregnancy and pregnancy outcome at a rural teaching hospital in India

Background: Teenage pregnancy accounts for 11% of births worldwide and 95% of these occur in low middle income countries. Pregnancy and its complications are leading cause of death among these girls. This study was done to know the prevalence and to determine whether teenage mothers are at risk of adverse pregnancy outcome.Methods: A retrospective study was conducted at a tertiary teaching hospital, India between July 2015 to Dec, 2017. All teenage mothers delivered after 28 weeks of gestation were included. Women with Diabetes mellitus, renal disease, thyroid disorders were excluded. Demographic data, maternal complications like anaemia, hypertensive disorders of pregnancy, preterm birth, mode of delivery, low birth weight, NICU admissions, stillbirth and early neonatal death were recorded.Results: In the present study, the prevalence was 7% which is less than that of other studies. Incidence of caesarean-Section in the present study was 31%. Amongst the complications oligohydramnious was found to be significantly associated with teenage pregnancy. NICU admissions were needed for 43% of the cases and 31% were LBW.Conclusions: High NICU admission and high LBW in newborns of teenage mothers were noted in the current study. Hence, there is urgent need to focus on the teenage pregnancy

Antiinflammatory Therapy with Canakinumab for Atherosclerotic Disease

Background: Experimental and clinical data suggest that reducing inflammation without affecting lipid levels may reduce the risk of cardiovascular disease. Yet, the inflammatory hypothesis of atherothrombosis has remained unproved. Methods: We conducted a randomized, double-blind trial of canakinumab, a therapeutic monoclonal antibody targeting interleukin-1β, involving 10,061 patients with previous myocardial infarction and a high-sensitivity C-reactive protein level of 2 mg or more per liter. The trial compared three doses of canakinumab (50 mg, 150 mg, and 300 mg, administered subcutaneously every 3 months) with placebo. The primary efficacy end point was nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death. RESULTS: At 48 months, the median reduction from baseline in the high-sensitivity C-reactive protein level was 26 percentage points greater in the group that received the 50-mg dose of canakinumab, 37 percentage points greater in the 150-mg group, and 41 percentage points greater in the 300-mg group than in the placebo group. Canakinumab did not reduce lipid levels from baseline. At a median follow-up of 3.7 years, the incidence rate for the primary end point was 4.50 events per 100 person-years in the placebo group, 4.11 events per 100 person-years in the 50-mg group, 3.86 events per 100 person-years in the 150-mg group, and 3.90 events per 100 person-years in the 300-mg group. The hazard ratios as compared with placebo were as follows: in the 50-mg group, 0.93 (95% confidence interval [CI], 0.80 to 1.07; P = 0.30); in the 150-mg group, 0.85 (95% CI, 0.74 to 0.98; P = 0.021); and in the 300-mg group, 0.86 (95% CI, 0.75 to 0.99; P = 0.031). The 150-mg dose, but not the other doses, met the prespecified multiplicity-adjusted threshold for statistical significance for the primary end point and the secondary end point that additionally included hospitalization for unstable angina that led to urgent revascularization (hazard ratio vs. placebo, 0.83; 95% CI, 0.73 to 0.95; P = 0.005). Canakinumab was associated with a higher incidence of fatal infection than was placebo. There was no significant difference in all-cause mortality (hazard ratio for all canakinumab doses vs. placebo, 0.94; 95% CI, 0.83 to 1.06; P = 0.31). Conclusions: Antiinflammatory therapy targeting the interleukin-1β innate immunity pathway with canakinumab at a dose of 150 mg every 3 months led to a significantly lower rate of recurrent cardiovascular events than placebo, independent of lipid-level lowering. (Funded by Novartis; CANTOS ClinicalTrials.gov number, NCT01327846.

Cardiovascular Efficacy and Safety of Bococizumab in High-Risk Patients

Bococizumab is a humanized monoclonal antibody that inhibits proprotein convertase subtilisin- kexin type 9 (PCSK9) and reduces levels of low-density lipoprotein (LDL) cholesterol. We sought to evaluate the efficacy of bococizumab in patients at high cardiovascular risk. METHODS In two parallel, multinational trials with different entry criteria for LDL cholesterol levels, we randomly assigned the 27,438 patients in the combined trials to receive bococizumab (at a dose of 150 mg) subcutaneously every 2 weeks or placebo. The primary end point was nonfatal myocardial infarction, nonfatal stroke, hospitalization for unstable angina requiring urgent revascularization, or cardiovascular death; 93% of the patients were receiving statin therapy at baseline. The trials were stopped early after the sponsor elected to discontinue the development of bococizumab owing in part to the development of high rates of antidrug antibodies, as seen in data from other studies in the program. The median follow-up was 10 months. RESULTS At 14 weeks, patients in the combined trials had a mean change from baseline in LDL cholesterol levels of -56.0% in the bococizumab group and +2.9% in the placebo group, for a between-group difference of -59.0 percentage points (P<0.001) and a median reduction from baseline of 64.2% (P<0.001). In the lower-risk, shorter-duration trial (in which the patients had a baseline LDL cholesterol level of ≥70 mg per deciliter [1.8 mmol per liter] and the median follow-up was 7 months), major cardiovascular events occurred in 173 patients each in the bococizumab group and the placebo group (hazard ratio, 0.99; 95% confidence interval [CI], 0.80 to 1.22; P = 0.94). In the higher-risk, longer-duration trial (in which the patients had a baseline LDL cholesterol level of ≥100 mg per deciliter [2.6 mmol per liter] and the median follow-up was 12 months), major cardiovascular events occurred in 179 and 224 patients, respectively (hazard ratio, 0.79; 95% CI, 0.65 to 0.97; P = 0.02). The hazard ratio for the primary end point in the combined trials was 0.88 (95% CI, 0.76 to 1.02; P = 0.08). Injection-site reactions were more common in the bococizumab group than in the placebo group (10.4% vs. 1.3%, P<0.001). CONCLUSIONS In two randomized trials comparing the PCSK9 inhibitor bococizumab with placebo, bococizumab had no benefit with respect to major adverse cardiovascular events in the trial involving lower-risk patients but did have a significant benefit in the trial involving higher-risk patients

Antiinflammatory therapy with canakinumab for atherosclerotic disease

BACKGROUND: Experimental and clinical data suggest that reducing inflammation without affecting lipid levels may reduce the risk of cardiovascular disease. Yet, the inflammatory hypothesis of atherothrombosis has remained unproved. METHODS: We conducted a randomized, double-blind trial of canakinumab, a therapeutic monoclonal antibody targeting interleukin-1β, involving 10,061 patients with previous myocardial infarction and a high-sensitivity C-reactive protein level of 2 mg or more per liter. The trial compared three doses of canakinumab (50 mg, 150 mg, and 300 mg, administered subcutaneously every 3 months) with placebo. The primary efficacy end point was nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death. RESULTS: At 48 months, the median reduction from baseline in the high-sensitivity C-reactive protein level was 26 percentage points greater in the group that received the 50-mg dose of canakinumab, 37 percentage points greater in the 150-mg group, and 41 percentage points greater in the 300-mg group than in the placebo group. Canakinumab did not reduce lipid levels from baseline. At a median follow-up of 3.7 years, the incidence rate for the primary end point was 4.50 events per 100 person-years in the placebo group, 4.11 events per 100 person-years in the 50-mg group, 3.86 events per 100 person-years in the 150-mg group, and 3.90 events per 100 person-years in the 300-mg group. The hazard ratios as compared with placebo were as follows: in the 50-mg group, 0.93 (95% confidence interval [CI], 0.80 to 1.07; P=0.30); in the 150-mg group, 0.85 (95% CI, 0.74 to 0.98; P=0.021); and in the 300-mg group, 0.86 (95% CI, 0.75 to 0.99; P=0.031). The 150-mg dose, but not the other doses, met the prespecified multiplicity-adjusted threshold for statistical significance for the primary end point and the secondary end point that additionally included hospitalization for unstable angina that led to urgent revascularization (hazard ratio vs. placebo, 0.83; 95% CI, 0.73 to 0.95; P=0.005). Canakinumab was associated with a higher incidence of fatal infection than was placebo. There was no significant difference in all-cause mortality (hazard ratio for all canakinumab doses vs. placebo, 0.94; 95% CI, 0.83 to 1.06; P=0.31). CONCLUSIONS: Antiinflammatory therapy targeting the interleukin-1β innate immunity pathway with canakinumab at a dose of 150 mg every 3 months led to a significantly lower rate of recurrent cardiovascular events than placebo, independent of lipid-level lowering. Copyright © 2017 Massachusetts Medical Society