BackgroundMaternal serum concentrations of folate, homocysteine, and vitamin B12 have been associated with pre-eclampsia. Nevertheless, reported studies involve limited number of cases to reliably assess the nature of these associations. Our aim was to examine the relation of these three biomarkers with pre-eclampsia risk in a large Colombian population.Materials and methodsDesign: A case-control study.Setting: Cases of pre-eclampsia and healthy pregnant controls were recruited at the time of delivery from eight different Colombian cities between 2000 and 2012.Population or Sample: 2978 cases and 4096 controls were studied. Maternal serum concentrations of folate, homocysteine, and vitamin B12 were determined in 1148 (43.6%) cases and 1300 (31.7%) controls. Also, self-reported folic acid supplementation was recorded for 2563 (84%) cases and 3155 (84%) controls.Analysis: Adjusted odds ratios (OR) for pre-eclampsia were estimated for one standard deviation (1SD) increase in log-transformed biomarkers. Furthermore, we conducted analyses to compare women that reported taking folic acid supplementation for different periods during pregnancy.Main Outcomes Measures: Odds ratio for pre-eclampsia.ResultsAfter adjusting for potential confounders in logistic regression models, the OR for pre-eclampsia was 0.80 (95% CI: 0.72, 0.90) for 1SD increase in log-folate, 1.16 (95%CI: 1.05, 1.27) for 1SD increase in log-homocysteine, and 1.10 (95%CI: 0.99, 1.22) for 1SD increase in log-vitamin B12. No interactions among the biomarkers were identified. Women who self-reported consumption of folic acid (1 mg/day) throughout their pregnancy had an adjusted OR for pre-eclampsia of 0.86 (95%CI: 0.67, 1.09) compared to women that reported no consumption of folic acid at any point during pregnancy.ConclusionsMaternal serum concentrations of folate were associated as a protective factor for pre-eclampsia while concentrations of homocysteine were associated as a risk factor. No association between maternal vitamin B12 concentrations and preeclampsia was found.

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Background Atherosclerotic cardiovascular disease (ASCVD) is the leading cause of mortality worldwide, with a prevalence of approximately 100 million patients. There is evidence that antiplatelet agents and antihypertensive medications could reduce the risk of new vascular events in this population; however, treatment adherence is very low. An SMS text messaging intervention was recently developed based on behavior change techniques to increase adherence to pharmacological treatment among patients with a history of ASCVD. Objective This study aims to evaluate the efficacy and safety of an SMS text messaging intervention to improve adherence to cardiovascular medications in patients with ASCVD. Methods A randomized controlled clinical trial for patients with a prior diagnosis of cardiovascular events, such as acute myocardial infarction, unstable angina, cerebrovascular disease, or peripheral artery disease, in one center in Colombia was conducted. Patients randomized to the intervention arm were assigned to receive SMS text messages daily for the first 4 weeks, 5 SMS text messages on week 5, 3 SMS text messages each in weeks 6 and 7, and 1 SMS text message weekly from week 8 until week 52. In contrast, patients in the control arm received a monthly SMS text message reminding them of the next study appointment and the importance of the study, requesting information about changes in their phone number, and thanking them for participating in the study. The primary endpoint was the change in low-density lipoprotein cholesterol (LDL-C) levels, whereas the secondary endpoints were the changes in thromboxane B2 levels, heart rate, systolic and diastolic blood pressure, medication adherence, cardiac and noncardiac mortality, and hospitalization. Linear regression analyses and bivariate tests were performed. Results Of the 930 randomized patients, 805 (86.5%) completed follow-up and were analyzed for the primary endpoint. There was no evidence that the intervention changed the primary outcome (LDL-C levels; P=.41) or any of the secondary outcomes evaluated (all P>.05). There was also no evidence that the intervention was associated with adverse events. Conclusions In this study, there was no evidence that a behavior modification intervention delivered by SMS text messaging improved LDL-C levels, blood pressure levels, or adherence at 12 months. More research is needed to evaluate whether different SMS text messaging strategies, including personalized messages and different timings, are effective; future studies should include mixed methods to better understand why, for whom, and in which context (eg, health system or social environment) SMS text messaging interventions work (or not) to improve adherence in patients with ASCVD. Trial Registration ClinicalTrials.gov NCT03098186; https://clinicaltrials.gov/ct2/show/NCT03098186 International Registered Report Identifier (IRRID) RR2-10.1136/bmjopen-2018-028017

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IntroductionAnti-platelet therapy, angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers, beta-blockers and statins are cost-effective in patients with atherosclerotic cardiovascular diseases (ASCVD) for reducing the risk of ASCVD events. Unfortunately, there is abundant evidence that adherence to these cardiovascular medications is far from ideal. A recent Cochrane review showed a potential beneficial effect of Short Message Service (SMS) interventions on adherence to medication in ASCVD patients.Methods and analysisThe txt2heart study is a pragmatic randomised single-blind controlled trial. The objective is to evaluate the efficacy and safety of an intervention with SMS messages delivered by mobile phones to improve adherence to cardiovascular medications in patients with ASCVD. The intervention consists of behavioural techniques delivered via SMS. The primary outcome is change in blood serum low-density lipoprotein cholesterol levels as an indicator of adherence to statins. Secondary outcomes will include systolic blood pressure as an indicator of adherence to blood-lowering therapies and heart rate as an indicator of adherence to beta-blockers, urine levels of 11-dehydrothromboxane B2, self-reported adherence to cardiovascular medications and rates of cardiovascular death or hospitalisation due to cardiovascular disease.Ethics and disseminationThe study will be performed in compliance with the protocol, regulatory requirements, Good Clinical Practice and ethical principles of the Declaration of Helsinki. The Ethics Committee of Fundación Cardiovascular de Colombia evaluated and approved the trial. The txt2heart Colombia trial aims to provide robust evidence to evaluate whether SMS messages delivered through mobile telephones change the behaviour of Colombian patients who have suffered a cardiovascular event. Trial results will be presented to the local health authorities, and if the intervention is effective and safe, we hope this strategy will be implemented quickly because of its low cost and wide-reaching impact on the population.Trial registration number NCT03098186.