TY - JOUR
T1 - Design, rationale and protocol for Glycemic Observation and Metabolic Outcomes in Mothers and Offspring (GO MOMs)
T2 - An observational cohort study
AU - The GO MOMs Study Group
AU - Scholtens, Denise
AU - Leblanc, Erin S.
AU - Vesco, Kimberly K.
AU - Amy, David
AU - Bays, Kristi
AU - Massimino, Stefan
AU - Robinson, Sperry
AU - Schell, Katrina
AU - Hillier, Teresa A.
AU - Oshiro, Caryn
AU - Cordero, Sandra
AU - Howick, Connor
AU - Kim, Lisa
AU - Martinez, Yannica Theda
AU - Pishchalenko, Olena
AU - Wastlova, Vladka
AU - Walters, Gillian A.
AU - Zork, Noelia
AU - Mourad, Mirella
AU - Lonier, Jacqueline
AU - Reddy, Uma
AU - Acevedo, Jayleen
AU - Castillo, Jose
AU - Gomez, Michael
AU - Peguero, Belgica
AU - Facco, Francesca
AU - Feghali, Maisa
AU - Bocan, Heather
AU - Stramowski, Savannah
AU - Powe, Camille E.
AU - Edlow, Andrea
AU - Barth, William
AU - Nathan, David
AU - Azevedo, Robin
AU - Baez, Arantxa Medina
AU - Iroajanma, Chinenye
AU - Larkin, Mary
AU - Maya, Jacqueline
AU - Michalopolous, Chloe
AU - Neamonitaki, Nefeli
AU - Thangthaeng, Nopporn
AU - Yee, Lynn
AU - Lowe, William
AU - Grobman, William
AU - Szmuilowicz, Emily
AU - Aguirre, Alyssa
AU - Guevara, Evelyn
AU - Mallett, Gail
AU - Matos, Samantha
AU - Siddique, Juned
N1 - Publisher Copyright:
© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2024/6/8
Y1 - 2024/6/8
N2 - 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.
AB - 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.
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U2 - 10.1136/bmjopen-2024-084216
DO - 10.1136/bmjopen-2024-084216
M3 - Article
C2 - 38851233
AN - SCOPUS:85196087962
SN - 2044-6055
VL - 14
JO - BMJ open
JF - BMJ open
IS - 6
M1 - e084216
ER -