EMERGE Mothers and Kids: a longitudinal cohort study of mothers and children enrolled in the randomized placebo-controlled trial of metformin in women with GDM (EMERGE): study protocol
Abstract
Background: Pregnancies complicated by gestational diabetes mellitus (GDM) are associated with increased risks of adverse perinatal outcomes and with long-term metabolic and cardiovascular consequences for both mother and child. The original EMERGE randomized controlled trial (RCT) evaluated the effectiveness of early metformin in addition to usual care in women with GDM on glycemic control and perinatal outcomes. The primary objective of the EMERGE Mothers and Kids study is to evaluate long-term maternal cardiometabolic health and child anthropometric and neurodevelopmental outcomes following participation in the EMERGE trial.
Methods: This is a prospective, observational longitudinal cohort follow-up study of women and their children previously enrolled in the EMERGE trial (NCT06327191). Participants are invited to attend a follow-up visit in a single-site hospital-based clinical research setting at the Clinical Research Facility Galway, Ireland. Key inclusion criteria are women and their children who participated in the EMERGE trial and consent to follow-up. Key exclusion criteria include participants who did not provide consent for future follow-up studies. The planned follow-up sample is a pragmatic convenience sample of up to 321 mother-child pairs. A single follow-up visit will be conducted up to 6 years after the index pregnancy. Maternal assessments include anthropometric data, glucose tolerance, and metabolic parameters. Child assessments include growth metrics,…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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