An observational study in Gestational Diabetes and Pregnancy Related, sponsored by Northwestern University. Completed at 9 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-16.
Sponsored by Northwestern University · Observational
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.
GO MOMs is an observational study designed to characterize the glycemic profile of pregnancy using continuous glucose monitoring (CGM) technology in order to develop criteria using CGM measurements and/or early pregnancy oral glucose tolerance testing (OGTT) at 10w0d-14w0d gestation that are predictive, along with clinical factors, of adverse pregnancy outcomes in mothers and their newborns. GO MOMs involves multiple institutions and an anticipated 2179 participants. Participants will attend 4 research study visits: Visit 1 (10w0d-14w0d gestation), Visit 2 (16w0d-20w0d gestation), Visit 3 (24w0d-28w0d gestation), and Visit 4 (32w0d-36w0d gestation). Additional data will be collected at a Delivery Visit and via chart abstraction. Mothers will have a Remote Follow-up call after delivery to collect additional data. At Visits 1-4, a blinded CGM sensor will be placed. Participants will be instructed to wear the sensor for 10 days after which time they will follow instructions to return it to their study site. At Visit 1 (10w0d-14w0d gestation), participants will undergo a 75 g 2-hour (hr) OGTT. At Visit 3 (24w0d-28w0d gestation), participants will undergo a 100 g 3 hr OGTT. Visit 1 will include an extended maternal interview to collect social and demographic, medical history, obstetrical history, surgical history, family medical history, current health and pregnancy, and lifestyle (sleep, alcohol, tobacco use) data. Medical history, alcohol and tobacco use data will be updated at each study visit. Sleep data will be updated at Visit 3 (24w0d-28w0d gestation). Blood and urine samples will also be obtained at each visit for additional laboratory testing and some will be stored for ancillary investigations. At the Delivery Visit, newborn physical measurements including weight, length and skinfolds will be performed. Birthweight at delivery will also be obtained through chart abstraction. Primary statistical analyses will be performed to develop predictive criteria based on CGM and/or OGTT measures at Visit 1 (10w0d-14w0d gestation) along with clinical factors for primary maternal and newborn outcomes. Secondary analyses will further refine predictive models and will evaluate associations of maternal glucose with secondary outcomes and longitudinal modeling of maternal glycemia over the course of pregnancy.
GO MOMs Nutrition Substudy: The GO MOMs Nutrition Study is an observational substudy nested within the GO MOMs parent study. The goal of the study is to describe self-reported dietary components in a diverse cohort of pregnant individuals and to study the relationship between maternal diet and outcomes including maternal glycemia, maternal insulin physiology, infant birth weight, and infant fat mass. Participants will complete 6 dietary recalls via the Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool during their pregnancies (Figure). Two will occur at visits and four will be unannounced, meaning they are completed on a random day without advance notice, during CGM wear. In addition, stored samples from all GO MOMs participants at visit 1 and 3 will be assayed for other nutritional markers. Primary statistical analyses will be used to identify associations between dietary carbohydrate content at \<22 weeks' gestation and maternal glycemia 24-28 weeks' gestation and neonatal birthweight.
842 studies on the registry are indexed under Diabetes, Gestational; 198 are open to participants now.
This study's enrollment of 2,179 is above the median of 200 across 269 observational studies indexed under Diabetes, Gestational.
Browse Diabetes, Gestational studies →Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.
Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.
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Pregnant adults who enroll prior to 10w0d-14w0d gestation.
Exclusion Criteria:
Other: Observational
Observational
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).
Time frame: 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.
Time frame: Delivery
Hypertension
Secondary outcome in GO MOMs mothers: Number of mothers with hypertensive disorders of pregnancy including preeclampsia with and without severe features, gestational hypertension, eclampsia, and Hemolysis, Elevated Liver enzymes, and Low Platelet count (HELLP) syndrome, defined by the American College of Obstetricians and Gynecologists (ACOG) criteria
Time frame: Evaluated 30-90 days after delivery through chart abstraction for any events occurring during pregnancy
Cesarean delivery
Secondary outcome in GO MOMs mothers: Number of mothers with cesarean delivery
Time frame: Delivery
Sum of skinfolds
Secondary outcome in GO MOMs newborns: Newborn sum of flank, triceps, and subscapular skinfolds, evaluated as a continuous measure and dichotomized as \>90th percentile.
Time frame: Within 72 hours after delivery
Small for gestational age (SGA)
Secondary outcome in GO MOMs newborns: Number of newborns who are small for gestational age (SGA), defined as birthweight \< 10th percentile for gestational age according to Aris et al. (2019)
Time frame: Delivery
Preterm birth
Secondary outcome in GO MOMs newborns: Number of newborns with preterm birth, defined as delivery prior to estimated gestational age 37 weeks 0 days.
Time frame: Delivery
Shoulder dystocia
Secondary outcome in GO MOMs newborns: Number of newborns with shoulder dystocia, identified through chart abstraction and defined clinically, requiring documentation that providers applied maneuvers to reduce the shoulder at delivery.
Time frame: Delivery
Neonatal birth injury
Secondary outcome in GO MOMs newborns: Number of newborns with neonatal birth injury, identified through chart abstraction and defined as brachial plexus palsy or clavicular, humeral, or skull fracture.
Time frame: Delivery
Neonatal hypoglycemia
Secondary outcome in GO MOMs newborns: Number of newborns with neonatal hypoglycemia, identified through chart abstraction and defined as treated neonatal hypoglycemia.
Time frame: Within 30 days after delivery
Neonatal respiratory morbidity
Secondary outcome in GO MOMs newborns: Number of newborns with neonatal respiratory morbidity, identified through chart abstraction and defined as need for respiratory support within 72 hrs after birth and consisting of one or more of the following: the use of continuous positive airway pressure (CPAP) or high-flow nasal cannula for at least 2 consecutive hrs, supplemental oxygen with a fraction of inspired oxygen of at least 0.30 for at least 4 continuous hrs, extracorporeal membrane oxygenation (ECMO), or mechanical ventilation. A high flow of air or blended air and oxygen is defined as more than 1 liter per minute
Time frame: Within 30 days after delivery
Neonatal hyperbilirubinemia
Secondary outcome in GO MOMs newborns: Number of newborns with neonatal hyperbilirubinemia, identified through chart abstraction and defined as treatment of hyperbilirubinemia in the first week of life with phototherapy or exchange transfusion or a diagnosis of kernicterus.
Time frame: Within 30 days after delivery
Nutrition Substudy: Mean CGM glucose in mothers
Outcome in mothers for Nutrition Substudy: Mean CGM glucose at 24-28 weeks' gestation in mothers
Time frame: When participants are between 24 weeks 0 days pregnant to 28 weeks 0 days pregnant
Nutrition Substudy: Percent time above various glycemic thresholds at 24-28 weeks
Secondary outcome in mothers for Nutrition Substudy: Percent time above various glycemic thresholds: 100 miligrams/deciliter, 105 miligrams/deciliter, 110 miligrams/deciliter, 120 miligrams/deciliter, 140 miligrams/deciliter, as measured by continuous glucose monitor at 24-28 weeks' gestation.
Time frame: When participants are between 24 weeks 0 days pregnant to 28 weeks 0 days pregnant
Nutrition Substudy: Mean nocturnal glucose
Secondary outcome in mothers for Nutrition Substudy: Mean nocturnal glucose (12am-6am) in miligrams/deciliter, as measured by continuous glucose monitor at 24-28 weeks' gestation.
Time frame: When participants are between 24 weeks 0 days pregnant to 28 weeks 0 days pregnant
Nutrition Substudy: Percent time above various glycemic thresholds at 16-36 weeks
Secondary outcome in mothers for Nutrition Substudy: Maternal continuous glucose monitor-assessed glucose defined as percent time above various glycemic thresholds: 100 miligrams/deciliter, 105 miligrams/deciliter, 110 miligrams/deciliter, 120 miligrams/deciliter, 140 miligrams/deciliter, as measured by continuous glucose monitor at 16-20, 24-28, and 32-36 weeks' gestation.
Time frame: When participants are between 16 weeks 0 days pregnant to 36 weeks 0 days pregnant
Nutrition Substudy: Insulin resistance
Secondary outcome in mothers for Nutrition Substudy: Insulin resistance, as estimated by the Matsuda index quantified during the oral glucose tolerance test at 24-28 weeks' gestation. The Matsuda index calculates whole body insulin resistance, with insulin resistance defined as being equal to or lower than 2.5.
Time frame: When participants are between 24 weeks 0 days pregnant to 28 weeks 0 days pregnant
Nutrition Substudy: Insulin secretory response
Secondary outcome in mothers for Nutrition Substudy: Insulin secretory response, as estimated by the ratio of insulin area under the curve to glucose area under the curve, during oral glucose tolerance test at 24-28 weeks' gestation.
Time frame: When participants are between 24 weeks 0 days pregnant to 28 weeks 0 days pregnant
Nutrition Substudy: gestational diabetes mellitus diagnosis
Secondary outcome in mothers for Nutrition Substudy: Gestational diabetes mellitus, diagnosed using Carpenter-Coustan criteria applied to an oral glucose tolerance test at 24-28 weeks' gestation.
Time frame: When participants are between 24 weeks 0 days pregnant to 28 weeks 0 days pregnant
Nutrition Substudy: Neonatal fat mass
Secondary outcome in newborns for Nutrition Substudy: Neonatal fat mass as estimated by flank skinfold, measured as percent body fat, within 72 hours of delivery.
Time frame: Within 72 hours of delivery
Nutrition Substudy: large for gestational age birthweight
Secondary outcome in newborns for Nutrition Substudy: Large for gestational age birth weight defined as birth weight \> 90th percentile for gestational age.
Time frame: Delivery
Nutrition Substudy: Birthweight for gestational age percentile
Secondary outcome for newborns for Nutrition Substudy: Birthweight for gestational age percentile. The first weight after delivery from the medical record will be used for defining this outcome.
Time frame: Delivery
Neonatal intensive care unit (NICU) admissions
Exploratory outcome in GO MOMs newborns: Number of newborns with neonatal intensive care unit (NICU) admissions
Time frame: Within 30 days after delivery
Length of hospital admission
Exploratory outcome in GO MOMs newborns: Length of admission/length of stay (for NICU or entire delivery hospitalization) for newborns
Time frame: Within 30 days after delivery
Spontaneous abortion
Exploratory outcome in GO MOMs mothers: Spontaneous abortion (\< 20 weeks of gestation)
Time frame: Prior to 20 weeks' gestation
Stillbirth
Exploratory outcome in GO MOMs newborns: Number of mothers with stillbirth (intrauterine fetal demise at 20 weeks of gestation or later)
Time frame: Delivery
Neonatal death
Exploratory outcome in GO MOMs newborns: Number of newborns with neonatal death
Time frame: Within 30 days after delivery
Major congenital malformation
Exploratory outcome in GO MOMs newborns: Number of newborns with major congenital malformation
Time frame: Within 30 days after delivery
Antepartum admissions or maternal readmissions
Exploratory outcome in GO MOMs mothers: Number of mothers with antepartum admissions or maternal readmissions
Time frame: Within 30 days after delivery
Apgar score <7 at 5 minutes
Exploratory outcome in GO MOMs newborns: Number of newborns with Apgar score \<7 at 5 minutes
Time frame: Delivery
Nutrition Substudy: Maternal fasting triglycerides
Exploratory outcome in mothers for Nutrition Substudy: Maternal fasting triglycerides as measured in miligrams/deciliter at 24-28 weeks' gestation.
Time frame: When participants are between 24 weeks 0 days pregnant to 28 weeks 0 days pregnant
Nutrition Substudy: Maternal fasting free fatty acids
Exploratory outcome in mothers for Nutrition Substudy: Maternal fasting free fatty acids as measured in millimoles per liter at 24-28 weeks' gestation.
Time frame: When participants are between 24 weeks 0 days pregnant to 28 weeks 0 days pregnant
Plan to share: Yes — Participants have the option to agree to share dataset with National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Repository.
Supporting information: Study protocol
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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