Design, rationale and protocol for Glycemic Observation and Metabolic Outcomes in Mothers and Offspring (GO MOMs): an observational cohort study
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 individual...
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BMJ Publishing Group
2024-06-01
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| author | Erin S LeBlanc Mary Larkin José Castillo Erika Werner William Lowe Michael Gomez David Amy Afshin Azimirad Camille E Powe Denise Scholtens Kimberly K Vesco Kristi Bays Stefan Massimino Sperry Robinson Katrina Schell Gillian A Walters Teresa A Hillier Caryn Oshiro Sandra Cordero Connor Howick Lisa Kim Yannica Theda Martinez Olena Pishchalenko Vladka Wastlova Noelia Zork Mirella Mourad Jacqueline Lonier Uma Reddy Jayleen Acevedo Belgica Peguero Francesca Facco Maisa Feghali Heather Bocan Savannah Stramowski Andrea Edlow William Barth David Nathan Robin Azevedo Arantxa Medina Baez Chinenye Iroajanma Jacqueline Maya Nefeli Neamonitaki Nopporn Thangthaeng Lynn Yee William Grobman Emily Szmuilowicz Alyssa Aguirre Evelyn Guevara Gail Mallett Samantha Matos Shubhi Tyagi Alexandra Spadola Patrick Catalano Dwight Rouse Madeline Malloy Floralba Parra Jennifer Sherr Audrey Merriam Sherrie Bitterman Elizabeth Considine Jessica Leventhal Lauren Perley Linda Rink Amy Steffen Beatrix Thompson Melinda Zgorski Michael Steffes Valerie Arends Anthony Killeen Juned Siddique Patricia Bustamante Ying (Jennifer) Cheung Carmen Edith Freeze Tania Grott Alan Kuang Mary Beth Tull Barbara Linder Chloe Michalopoulos |
| author_facet | Erin S LeBlanc Mary Larkin José Castillo Erika Werner William Lowe Michael Gomez David Amy Afshin Azimirad Camille E Powe Denise Scholtens Kimberly K Vesco Kristi Bays Stefan Massimino Sperry Robinson Katrina Schell Gillian A Walters Teresa A Hillier Caryn Oshiro Sandra Cordero Connor Howick Lisa Kim Yannica Theda Martinez Olena Pishchalenko Vladka Wastlova Noelia Zork Mirella Mourad Jacqueline Lonier Uma Reddy Jayleen Acevedo Belgica Peguero Francesca Facco Maisa Feghali Heather Bocan Savannah Stramowski Andrea Edlow William Barth David Nathan Robin Azevedo Arantxa Medina Baez Chinenye Iroajanma Jacqueline Maya Nefeli Neamonitaki Nopporn Thangthaeng Lynn Yee William Grobman Emily Szmuilowicz Alyssa Aguirre Evelyn Guevara Gail Mallett Samantha Matos Shubhi Tyagi Alexandra Spadola Patrick Catalano Dwight Rouse Madeline Malloy Floralba Parra Jennifer Sherr Audrey Merriam Sherrie Bitterman Elizabeth Considine Jessica Leventhal Lauren Perley Linda Rink Amy Steffen Beatrix Thompson Melinda Zgorski Michael Steffes Valerie Arends Anthony Killeen Juned Siddique Patricia Bustamante Ying (Jennifer) Cheung Carmen Edith Freeze Tania Grott Alan Kuang Mary Beth Tull Barbara Linder Chloe Michalopoulos |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-57978e47ffe54cb89682201d95e9bde6 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2024-06-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-57978e47ffe54cb89682201d95e9bde62025-08-20T03:40:40ZengBMJ Publishing GroupBMJ Open2044-60552024-06-0114610.1136/bmjopen-2024-084216Design, rationale and protocol for Glycemic Observation and Metabolic Outcomes in Mothers and Offspring (GO MOMs): an observational cohort study 0Erin S LeBlanc1Mary LarkinJosé CastilloErika Werner2William LoweMichael GomezDavid AmyAfshin AzimiradCamille E Powe3Denise ScholtensKimberly K VescoKristi BaysStefan MassiminoSperry RobinsonKatrina SchellGillian A WaltersTeresa A HillierCaryn OshiroSandra CorderoConnor HowickLisa Kim4Yannica Theda MartinezOlena PishchalenkoVladka WastlovaNoelia ZorkMirella MouradJacqueline LonierUma ReddyJayleen AcevedoBelgica PegueroFrancesca FaccoMaisa FeghaliHeather BocanSavannah StramowskiAndrea EdlowWilliam BarthDavid NathanRobin AzevedoArantxa Medina BaezChinenye IroajanmaJacqueline MayaNefeli NeamonitakiNopporn ThangthaengLynn YeeWilliam GrobmanEmily SzmuilowiczAlyssa AguirreEvelyn GuevaraGail MallettSamantha MatosShubhi TyagiAlexandra SpadolaPatrick Catalano5Dwight RouseMadeline MalloyFloralba ParraJennifer SherrAudrey MerriamSherrie BittermanElizabeth ConsidineJessica LeventhalLauren PerleyLinda RinkAmy SteffenBeatrix ThompsonMelinda ZgorskiMichael SteffesValerie ArendsAnthony KilleenJuned SiddiquePatricia BustamanteYing (Jennifer) CheungCarmen Edith FreezeTania GrottAlan KuangMary Beth TullBarbara LinderChloe MichalopoulosUniversity of Southampton Faculty of Medicine, Southampton, UKKaiser Permanente Center for Health Research, Portland, Oregon, USATufts Medical Center, Boston, Massachusetts, USAMassachusetts General Hospital, Boston, Massachusetts, USA1Center for Personalized Cancer Therapy and Division of Hematology and Oncology, Department of Medicine, University of California San Diego, Moores Cancer Center, La Jolla, CA, USADepartment of Obstetrics and Gynecology, Tufts University, Medford, Oregon, USAIntroduction 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.https://bmjopen.bmj.com/content/14/6/e084216.full |
| spellingShingle | Erin S LeBlanc Mary Larkin José Castillo Erika Werner William Lowe Michael Gomez David Amy Afshin Azimirad Camille E Powe Denise Scholtens Kimberly K Vesco Kristi Bays Stefan Massimino Sperry Robinson Katrina Schell Gillian A Walters Teresa A Hillier Caryn Oshiro Sandra Cordero Connor Howick Lisa Kim Yannica Theda Martinez Olena Pishchalenko Vladka Wastlova Noelia Zork Mirella Mourad Jacqueline Lonier Uma Reddy Jayleen Acevedo Belgica Peguero Francesca Facco Maisa Feghali Heather Bocan Savannah Stramowski Andrea Edlow William Barth David Nathan Robin Azevedo Arantxa Medina Baez Chinenye Iroajanma Jacqueline Maya Nefeli Neamonitaki Nopporn Thangthaeng Lynn Yee William Grobman Emily Szmuilowicz Alyssa Aguirre Evelyn Guevara Gail Mallett Samantha Matos Shubhi Tyagi Alexandra Spadola Patrick Catalano Dwight Rouse Madeline Malloy Floralba Parra Jennifer Sherr Audrey Merriam Sherrie Bitterman Elizabeth Considine Jessica Leventhal Lauren Perley Linda Rink Amy Steffen Beatrix Thompson Melinda Zgorski Michael Steffes Valerie Arends Anthony Killeen Juned Siddique Patricia Bustamante Ying (Jennifer) Cheung Carmen Edith Freeze Tania Grott Alan Kuang Mary Beth Tull Barbara Linder Chloe Michalopoulos Design, rationale and protocol for Glycemic Observation and Metabolic Outcomes in Mothers and Offspring (GO MOMs): an observational cohort study BMJ Open |
| title | Design, rationale and protocol for Glycemic Observation and Metabolic Outcomes in Mothers and Offspring (GO MOMs): an observational cohort study |
| title_full | Design, rationale and protocol for Glycemic Observation and Metabolic Outcomes in Mothers and Offspring (GO MOMs): an observational cohort study |
| title_fullStr | Design, rationale and protocol for Glycemic Observation and Metabolic Outcomes in Mothers and Offspring (GO MOMs): an observational cohort study |
| title_full_unstemmed | Design, rationale and protocol for Glycemic Observation and Metabolic Outcomes in Mothers and Offspring (GO MOMs): an observational cohort study |
| title_short | Design, rationale and protocol for Glycemic Observation and Metabolic Outcomes in Mothers and Offspring (GO MOMs): an observational cohort study |
| title_sort | design rationale and protocol for glycemic observation and metabolic outcomes in mothers and offspring go moms an observational cohort study |
| url | https://bmjopen.bmj.com/content/14/6/e084216.full |
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