Glycemic Observation and Metabolic Outcomes in Mothers and Offspring

Pregnancy Related Clinical Trial

— GO MOMs  

Official title:

Glycemic Observation and Metabolic Outcomes in Mothers and Offspring / Glycemic Profile of Pregnancy Consortium

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04860336
• Other study ID #: GO MOMs
• Secondary ID: 1U01DK123759-015
• Status: Recruiting
• Start date: April 1, 2021
• Est. completion date: October 1, 2025

Study information

• Verified date: April 2024
• Source: Northwestern University
• Contact: Mary Beth Tull, MS
• Phone: 1 312 503 4746
• Email: gomoms[@]northwestern.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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 2150 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2150
• Est. completion date: October 1, 2025
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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").

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes
• Pregnancy Related

Intervention

Other:
• Observational
Observational

Locations

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

Sponsors (9)

Lead Sponsor	Collaborator
Northwestern University	Columbia University, Kaiser Permanente, Massachusetts General Hospital, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Tufts Medical Center, University of Pittsburgh, Women and Infants Hospital of Rhode Island, Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Neonatal intensive care unit (NICU) admissions	Exploratory outcome in GO MOMs newborns: Number of newborns with neonatal intensive care unit (NICU) admissions	Within 30 days after delivery
Other	Length of hospital admission	Exploratory outcome in GO MOMs newborns: Length of admission/length of stay (for NICU or entire delivery hospitalization) for newborns	Within 30 days after delivery
Other	Spontaneous abortion	Exploratory outcome in GO MOMs mothers: Spontaneous abortion (< 20 weeks of gestation)	Prior to 20 weeks' gestation
Other	Stillbirth	Exploratory outcome in GO MOMs newborns: Number of mothers with stillbirth (intrauterine fetal demise at 20 weeks of gestation or later)	Delivery
Other	Neonatal death	Exploratory outcome in GO MOMs newborns: Number of newborns with neonatal death	Within 30 days after delivery
Other	Major congenital malformation	Exploratory outcome in GO MOMs newborns: Number of newborns with major congenital malformation	Within 30 days after delivery
Other	Antepartum admissions or maternal readmissions	Exploratory outcome in GO MOMs mothers: Number of mothers with antepartum admissions or maternal readmissions	Within 30 days after delivery
Other	Apgar score <7 at 5 minutes	Exploratory outcome in GO MOMs newborns: Number of newborns with Apgar score <7 at 5 minutes	Delivery
Other	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.	When participants are between 24 weeks 0 days pregnant to 28 weeks 0 days pregnant
Other	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.	When participants are between 24 weeks 0 days pregnant to 28 weeks 0 days pregnant
Primary	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
Primary	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	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	Evaluated 30-90 days after delivery through chart abstraction for any events occurring during pregnancy
Secondary	Cesarean delivery	Secondary outcome in GO MOMs mothers: Number of mothers with cesarean delivery	Delivery
Secondary	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.	Within 72 hours after delivery
Secondary	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)	Delivery
Secondary	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.	Delivery
Secondary	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.	Delivery
Secondary	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.	Delivery
Secondary	Neonatal hypoglycemia	Secondary outcome in GO MOMs newborns: Number of newborns with neonatal hypoglycemia, identified through chart abstraction and defined as treated neonatal hypoglycemia.	Within 30 days after delivery
Secondary	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	Within 30 days after delivery
Secondary	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.	Within 30 days after delivery
Secondary	Nutrition Substudy: Mean CGM glucose in mothers	Outcome in mothers for Nutrition Substudy: Mean CGM glucose at 24-28 weeks' gestation in mothers	When participants are between 24 weeks 0 days pregnant to 28 weeks 0 days pregnant
Secondary	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.	When participants are between 24 weeks 0 days pregnant to 28 weeks 0 days pregnant
Secondary	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.	When participants are between 24 weeks 0 days pregnant to 28 weeks 0 days pregnant
Secondary	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.	When participants are between 16 weeks 0 days pregnant to 36 weeks 0 days pregnant
Secondary	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.	When participants are between 24 weeks 0 days pregnant to 28 weeks 0 days pregnant
Secondary	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.	When participants are between 24 weeks 0 days pregnant to 28 weeks 0 days pregnant
Secondary	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.	When participants are between 24 weeks 0 days pregnant to 28 weeks 0 days pregnant
Secondary	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.	Within 72 hours of delivery
Secondary	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.	Delivery
Secondary	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.	Delivery

External Links

•   Information about the study