Design, rationale and protocol for Glycemic Observation and Metabolic Outcomes in Mothers and Offspring (GO MOMs): An observational cohort study

The GO MOMs Study Group

Research output: Contribution to journalArticlepeer-review

Abstract

Introduction Given the increasing prevalence of both obesity and pre-diabetes in pregnant adults, there is growing interest in identifying hyperglycaemia in early pregnancy to optimise maternal and perinatal outcomes. Multiple organisations recommend first-trimester diabetes screening for individuals with risk factors; however, the benefits and drawbacks of detecting glucose abnormalities more mild than overt diabetes in early gestation and the best screening method to detect such abnormalities remain unclear. Methods and analysis The goal of the Glycemic Observation and Metabolic Outcomes in Mothers and Offspring study (GO MOMs) is to evaluate how early pregnancy glycaemia, measured using continuous glucose monitoring and oral glucose tolerance testing, relates to the diagnosis of gestational diabetes (GDM) at 24-28 weeks' gestation (maternal primary outcome) and large-for-gestational-age birth weight (newborn primary outcome). Secondary objectives include relating early pregnancy glycaemia to other adverse pregnancy outcomes and comprehensively detailing longitudinal changes in glucose over the course of pregnancy. GO MOMs enrolment began in April 2021 and will continue for 3.5 years with a target sample size of 2150 participants. Ethics and dissemination GO MOMs is centrally overseen by Vanderbilt University's Institutional Review Board and an Observational Study Monitoring Board appointed by National Institute of Diabetes and Digestive and Kidney Diseases. GO MOMs has potential to yield data that will improve understanding of hyperglycaemia in pregnancy, elucidate better approaches for early pregnancy GDM screening, and inform future clinical trials of early GDM treatment. Trial registration number NCT04860336.

Original languageEnglish (US)
Article numbere084216
JournalBMJ open
Volume14
Issue number6
DOIs
StatePublished - Jun 8 2024

Funding

This work is supported by grants from the National Institute of Diabetes and Digestive and Kidney Diseases: U01DK123795 to Massachusetts General Hospital; U01DK123791 to Kaiser Permanente; U01DK123759 and U01DK123745 to Northwestern University; U01DK123799 to Yale University; U01DK123783 to Women & Infants Hospital of Rhode Island. Dexcom provided the CGM systems used in the study free of charge. The GO MOMs Nutrition Study is supported by the National Institutes of Health Office of Nutrition Research.

ASJC Scopus subject areas

  • General Medicine

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