Paediatric and perinatal epidemiology
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Paediatr Perinat Epidemiol · Mar 2015
Randomized Controlled TrialRecruitment for longitudinal, randomised pregnancy trials initiated preconception: lessons from the effects of aspirin in gestation and reproduction trial.
Recruitment into large, preconception randomised clinical trials (RCT) is challenging. We describe clinic and community-based preconception recruitment strategies for the Effects of Aspirin in Gestation and Reproduction (EAGeR) trial and highlight approaches that were and were not successful. This longitudinal RCT was conducted at four major sites in the US. Eligible women had one to two prior pregnancy losses and were actively trying to become pregnant. ⋯ Provider and clinic-based recruitment was the most effective and cost-efficient method of recruitment in a preconception intervention study of reproduction among women.
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Paediatr Perinat Epidemiol · Nov 2013
Randomized Controlled Trial Multicenter StudyA randomised trial to evaluate the effects of low-dose aspirin in gestation and reproduction: design and baseline characteristics.
Low-dose aspirin (LDA) has been proposed to improve pregnancy outcomes in couples experiencing recurrent pregnancy loss. However, results from studies of LDA on pregnancy outcomes have been inconsistent, perhaps because most studies evaluated LDA-initiated post-conception. The purpose of the Effects of Aspirin in Gestation and Reproduction (EAGeR) trial was to determine whether preconception-initiated LDA improves livebirth rates in women with one to two prior losses. ⋯ We describe the study design, recruitment, data collection, and baseline characteristics of participants enrolled in EAGeR, which aimed to determine the effect of LDA on livebirth and other pregnancy outcomes in these women.
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Paediatr Perinat Epidemiol · Jul 2009
Randomized Controlled Trial Multicenter StudyDistribution of fasting plasma glucose and prevalence of impaired fasting glucose, impaired glucose tolerance and type 2 diabetes in the Mexican paediatric population.
Published data on the distribution of fasting plasma glucose (FPG) in children are scarce. We therefore set out to examine the distribution of FPG and determine the prevalence of impaired fasting glucose (IFG), impaired glucose tolerance (IGT) and type 2 diabetes (T2-DM) in Mexican children aged 6-18 years in a community-based cross-sectional study. A total of 1534 apparently healthy children were randomly enrolled and underwent an oral glucose tolerance test. ⋯ In the population overall, the prevalences of IFG, IGT, and T2-DM were 18.3%, 5.2% and 0.6%, respectively. Among obese children and adolescents, the prevalences of IFG, IGT, IFG + IGT and T2-DM were 19.1%, 5.7%, 2.5% and 1.3%. Our study shows a high prevalence of prediabetes and is the first that reports the distribution of FPG in Mexican children and adolescents.
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Paediatr Perinat Epidemiol · Apr 1998
Randomized Controlled Trial Clinical TrialA comparison of two methods of follow-up in a trial of prophylactic volume expansion in preterm babies.
The outcome at age 2 years of preterm babies recruited into a three-arm randomised controlled trial of prophylactic volume expansion was ascertained in two ways: from a neurodevelopmental assessment performed by a paediatrician and from responses on a brief questionnaire completed by the child's personal health visitor. Of 776 babies recruited into the trial, 604 survived to the age of 2 years and the findings of a paediatric assessment were available for all survivors. Questionnaires were sent to the health visitors of 601 of the survivors; 513 (85.4%) were returned. ⋯ The end point of the trial was death or severe disability at 2 years of age. There was close similarity in the trial results whether based on the paediatric assessment or on the questionnaire. Further refinement of the questionnaire is needed, but this methodology may be useful in ascertaining the frequency of severe disability in large cohorts of babies.