Glycemic Observation and Metabolic Outcomes in Mothers and Offspring

Completed

Conditions studied: Gestational Diabetes, Pregnancy Related

In brief

The overarching goal of Glycemic Observation and Metabolic Outcomes in Mothers and Offspring (GO MOMs) is to perform a comprehensive, longitudinal description of maternal glycemia over the course of pregnancy and to evaluate how glucose levels throughout pregnancy relate to traditional third trimester gestational diabetes mellitus (GDM) screening and perinatal outcomes.

Key facts

Study ID

NCT04860336

Run by

Northwestern University

People needed

2179

Starts

2021-04-01

Expected to finish

2025-07-18

Last updated by the study team

2026-04-16

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Maternal age >=18 at consent
• Singleton gestation
• 10w0d-14w0d gestation at the time of the Visit 1 OGTT and CGM placement according to study dating criteria
• Conceived using own oocyte
• Willing and able to wear CGM as directed and adhere to CGM instructions
• Planning to deliver at GO MOMs-affiliated hospital (see list of accrual sites in the protocol section "Key Roles and Contact Information").

You may not qualify if…

• Pre-existing diabetes at enrollment
• Currently self-monitoring blood glucose
• Current use of medication with glycemic effects
• Fetal malformation evident at or before enrollment that is likely lethal. This includes, but is not limited to, malformations such as anencephaly, hydrops, diffuse subcutaneous edema or cystic hygroma, ectopic cordis, and encephalocele
• Known fetal aneuploidy based on chorionic villus sampling
• Participation in other research study that may modify glycemic profile or study outcomes
• History of bariatric surgery
• Extensive skin changes or diseases making CGM sensor use problematic
• Significant allergy to adhesive
• Previous participation in GO MOMs
• Current bulimia or anorexia nervosa
• Overnight shift work that alters the sleep/wake periods
• Hemoglobin A1c >= 6.5%, fasting glucose >= 126 mg/dL or 2 hr glucose >= 200 mg/dL noted during OGTT at 10w0d-14w0d gestation
• Current psychiatric illness/social situation that would limit compliance with study requirements, as determined by the site investigator

Where it is running

• Yale University — New Haven, Connecticut, United States
• Kaiser Permanente - Hawaii — Honolulu, Hawaii, United States
• Northwestern University — Chicago, Illinois, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Columbia University — New York, New York, United States
• Kaiser Permanente - Northwest — Portland, Oregon, United States
• Magee Womens Research Institute & Foundation — Pittsburgh, Pennsylvania, United States
• Women and Infants Hospital of Rhode Island — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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