IMPORTANCEWomen with recent gestational diabetes (GDM) have increased risk of developing type 2 diabetes. OBJECTIVE To investigate whether a resource-appropriate and context-appropriate lifestyle intervention could prevent glycemic deterioration among women with recent GDM in South Asia. DESIGN, SETTING, AND PARTICIPANTS This randomized, participant-unblinded controlled trial investigated a 12-month lifestyle intervention vs usual care at 19 urban hospitals in India, Sri Lanka, and Bangladesh. Participants included women with recent diagnosis of GDM who did not have type 2 diabetes at an oral glucose tolerance test (OGTT) 3 to 18 months postpartum. They were enrolled
IMPORTANCECumulative exposure to high blood pressure (BP) is an adverse prognostic marker. Assessments of BP control over time, such as time at target, have been developed but assessments of the effects of BP-lowering interventions on such measures are lacking.OBJECTIVE To evaluate whether low-dose triple combination antihypertensive therapy was associated with greater rates of time at target compared with usual care. DESIGN, SETTING, AND PARTICIPANTSThe Triple Pill vs Usual Care Management for Patients With Mild-to-Moderate Hypertension (TRIUMPH) trial was a open-label randomized clinical trial of low-dose triple BP therapy vs usual care conducted in urban hospital clinics in Sri Lanka from February 2016 to May 2017. Adults with hypertension (systolic BP >140 mm Hg and/or diastolic BP >90 mm Hg or in patients with diabetes or chronic kidney disease, systolic BP >130 mm Hg and/or diastolic BP >80 mm Hg) requiring initiation (untreated patients) or escalation (patients receiving monotherapy) of antihypertensive therapy were included. Patients were excluded if they were currently taking 2 or more blood pressure-lowering drugs or had severe or uncontrolled blood pressure, accelerated hypertension or physician-determined need for slower titration of treatment, a contraindication to the triple combination pill therapy, an unstable medical condition, or clinically significant laboratory values deemed by researchers to be unsuitable for the study. All 700 individuals in the original trial were included in the secondary analysis. This post hoc analysis was conducted from December 2020 to December 2021.INTERVENTION Once-daily fixed-dose triple combination pill (telmisartan 20 mg, amlodipine 2.5 mg, and chlorthalidone 12.5 mg) therapy vs usual care.MAIN OUTCOMES AND MEASURES Between-group differences in time at target were compared over 24 weeks of follow-up, with time at target defined as percentage of time at target BP. RESULTS There were a total of 700 randomized patients (mean [SD] age, 56 [11] years; 403 [57.6%] women). Patients allocated to the triple pill group (n = 349) had higher time at target compared with those in the usual care group (n = 351) over 24 weeks' follow-up (64% vs 43%; risk difference, 21%; 95% CI, 16-26; P < .001). Almost twice as many patients receiving triple pill therapy achieved more than 50% time at target during follow-up (64% vs 37%; P < .001). The association of the triple pill with an increase in time at target was seen early, with most patients achieving more than 50% time at target by 12 weeks. Those receiving the triple pill achieved a consistently higher time at target at all follow-up periods compared with those receiving usual care (mean [SD]: 0-6 weeks, 36.3% [30.9%] vs 21.7% [28.9%]; P < .001; 6-12 weeks, 55.2% [31.9%] vs 33.7% [33.0%]; P < .001; 12-24 weeks, 66.0% [31.1%] vs 43.5% [34.3%]; P < .001). CONCLUSIONS AND RELEVANCETo our knowledge, this analysis provides the first estimate of time at target as an outcome assessing longitudinal BP control in a randomized clinical trial...
Background Respiratory distress (RD) is higher among newborns born by caesarean section (CS) compared to vaginal delivery. Royal College of Obstetricians and Gynaecologists recommend steroid administration for CS prior to 39 weeks. Effectiveness of steroids for neonatal RD at term is inconclusive. The racial differences are yet to be studied. Methods A single center retrospective cohort study was conducted in Colombo, Sri Lanka from December 2016 to February 2019. All mothers delivered by CS between 37+0 and 38+6 weeks were included. Mothers with severe maternal hypertension, fetal rhesus sensitization, intrauterine infection, multiple pregnancies and who received steroids at a prior gestation were excluded. Cohort was subdivided according to administration of intramuscular dexamethasone prior to CS. Primary outcomes measured were RD, admissions to neonatal intensive care unit (NICU) and special care baby unit (SCBU). Neonatal infections and maternal duration of hospital stay were recorded as secondary outcome measures. Results 560 patients were included. 23.2% of patients received antenatal corticosteroids. Incidence of RD, NICU admissions and SCBU admissions in the study cohort was 10%, 0.9%, and 2.7% respectively. Relative risk for developing RD in the steroid group compared to non-steroid group was 2.67 (95CI 1.64-4.35). 4.6% of the steroid group and 3.3% of the non-steroid group needed to be admitted to the NICU/SCBU (p=0.464). A significantly higher number of babies in the steroid group needed IV antibiotics. The average number of days the mothers were admitted to the hospital was 2.45 days (SD+/- 1.424) for steroid group and 1.4 days (SD+/- 0.856) for the non-steroid group (p < 0.001). Conclusions There is a significant increase in the respiratory morbidity in the dexamethasone administered south Asian mothers at term prior to CS. However, this effect has no clinical significance since the admissions to NICU and SCBU were not significantly different.
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