Glycemic Observation and Metabolic Outcomes in Mothers and Offspring

NCT04860336 | Completed DMC FDA Device

• 9 other identifiers: GO MOMs1U01DK123759-015U01DK123759-023U01DK123759-01S11U01DK123783-011U01DK123791-011U01DK123795-011U01DK123745-011U01DK123799-01
• Study Type: observational
• Target: 2,179
• Locations: 1 country
• Sites: 9

Brief Summary

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.

Conditions

Gestational Diabetes; Pregnancy Related

Keywords

gestational diabetes; continuous glucose monitor; oral glucose tolerance test; gestational diabetes mellitus; GDM; OGTT; CGM; glucose tolerance test; glycemic regulation; pregnancy; large for gestational age; observational

Outcome Measures

Primary Outcomes (2)

• Gestational diabetes (GDM)

  Primary outcome in GO MOMs mothers: Number of mothers diagnosed with gestational diabetes mellitus (GDM) using a 100 g 3 hr OGTT at 24w0d-28w0d gestation according to Carpenter-Coustan criteria (at least two of the timed glucose measurements greater than or equal to the following thresholds: fasting \>= 95 mg/dL, 1 hr \>= 180 mg/dL, 2 hr \>= 155 mg/dL, 3 hr \>= 140 mg/dL).

  When participants are between 24 weeks 0 days pregnant to 28 weeks 0 days pregnant

• Large for gestational age (LGA)

  Primary outcome in GO MOMs newborns: Number of newborns who are large for gestational age (LGA), defined as birthweight \>90th percentile for gestational age according to Aris et al. (2019). The first birthweight after delivery obtained from medical chart abstraction will be used for defining the primary LGA outcome.

  Delivery

Secondary Outcomes (20)

• Hypertension

  Evaluated 30-90 days after delivery through chart abstraction for any events occurring during pregnancy

• Cesarean delivery

  Delivery

• Sum of skinfolds

  Within 72 hours after delivery

• Small for gestational age (SGA)

  Delivery

• Preterm birth

  Delivery

Other Outcomes (10)

• Neonatal intensive care unit (NICU) admissions

  Within 30 days after delivery

• Length of hospital admission

  Within 30 days after delivery

• Spontaneous abortion

  Prior to 20 weeks' gestation

Study Arms (1)

Pregnant women less than or equal to 14w0d gestation

Other: Observational

Interventions

Observational OTHER

Observational

Pregnant women less than or equal to 14w0d gestation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant adults who enroll prior to 10w0d-14w0d gestation.

You may qualify if:

• Maternal age \>=18 at consent
• Singleton gestation
• w0d-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

Sponsors & Collaborators

• Northwestern University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Yale University: collaborator
• Women and Infants Hospital of Rhode Island: collaborator
• University of Pittsburgh: collaborator
• Massachusetts General Hospital: collaborator
• Tufts Medical Center: collaborator
• Columbia University: collaborator
• Kaiser Permanente: collaborator

Study Sites (9)

Yale University

New Haven, Connecticut, 06511, United States

Location

Kaiser Permanente - Hawaii

Honolulu, Hawaii, 96817, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Kaiser Permanente - Northwest

Portland, Oregon, 97227, United States

Location

Magee Womens Research Institute & Foundation

Pittsburgh, Pennsylvania, 15213, United States

Location

Women and Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

Location

Related Publications (1)

• GO MOMs Study Group. Design, rationale and protocol for Glycemic Observation and Metabolic Outcomes in Mothers and Offspring (GO MOMs): an observational cohort study. BMJ Open. 2024 Jun 8;14(6):e084216. doi: 10.1136/bmjopen-2024-084216.

  PMID: 38851233 DERIVED

Related Links

• Information about the study

Biospecimen

Retention: SAMPLES WITH DNA

Participants are given the option to have blood collected for future DNA analysis.

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Denise Scholtens, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 16, 2021
• First Posted: April 26, 2021
• Study Start: April 1, 2021
• Primary Completion: June 9, 2025
• Study Completion: July 18, 2025
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

US (9)