AzTrials
AzTrials

Gestational DiabetesGO MOMsNCT04860336

Glycemic Observation and Metabolic Outcomes in Mothers and Offspring

An observational study of Gestational Diabetes and Pregnancy Related, run by Northwestern University at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Gestational Diabetes, Pregnancy Related
What is being tested?
Observational
How many people
2,179 participants
Where
9 sitesUnited States
Study dates
1 Apr 2021to 18 Jul 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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").

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites
  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Northwestern University

    Chicago, Illinois, 60611

  • Kaiser Permanente - Hawaii

    Honolulu, Hawaii, 96817

  • Yale University

    New Haven, Connecticut, 06511

  • Columbia University

    New York, New York, 10032

  • Magee Womens Research Institute & Foundation

    Pittsburgh, Pennsylvania, 15213

  • Kaiser Permanente - Northwest

    Portland, Oregon, 97227

  • Women and Infants Hospital of Rhode Island

    Providence, Rhode Island, 02905

Other trials in United States

About this study

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

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.

Read the detailed 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 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.

Being tested
Observational
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
Medical subject headings
Diabetes, Gestational

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ObservationalOther

    Observational

Study groups in NCT04860336
Study groupRoleWhat they receive
Pregnant women less than or equal to 14w0d gestationNot described
Receives: Other: Observational

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

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

  2. 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.

    Measured: Delivery

Secondary outcomes (20)
  1. 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

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

  2. Cesarean delivery

    Secondary outcome in GO MOMs mothers: Number of mothers with cesarean delivery

    Measured: Delivery

  3. 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.

    Measured: Within 72 hours after delivery

  4. 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)

    Measured: Delivery

  5. 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.

    Measured: Delivery

  6. 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.

    Measured: Delivery

  7. 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.

    Measured: Delivery

  8. Neonatal hypoglycemia

    Secondary outcome in GO MOMs newborns: Number of newborns with neonatal hypoglycemia, identified through chart abstraction and defined as treated neonatal hypoglycemia.

    Measured: Within 30 days after delivery

  9. 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

    Measured: Within 30 days after delivery

  10. 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.

    Measured: Within 30 days after delivery

  11. Nutrition Substudy: Mean CGM glucose in mothers

    Outcome in mothers for Nutrition Substudy: Mean CGM glucose at 24-28 weeks' gestation in mothers

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

  12. 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.

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

  13. 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.

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

  14. 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.

    Measured: When participants are between 16 weeks 0 days pregnant to 36 weeks 0 days pregnant

  15. 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.

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

  16. 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.

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

  17. 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.

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

  18. 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.

    Measured: Within 72 hours of delivery

  19. 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.

    Measured: Delivery

  20. 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.

    Measured: Delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2021
  2. Study start1 Apr 2021
  3. Primary completion9 Jun 2025
  4. Study completion18 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,179 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04860336
Sponsor's protocol ID
GO MOMs
Other IDs
1U01DK123759-01, 5U01DK123759-02, 3U01DK123759-01S1, 1U01DK123783-01, 1U01DK123791-01, 1U01DK123795-01, 1U01DK123745-01, 1U01DK123799-01
Acronym
GO MOMs
Status last verified
Apr 2026
First submitted
16 Apr 2021
Last updated
16 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: Participants have the option to agree to share dataset with National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Repository.

Publications

  • 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.

    PubMed 38851233

Questions about this trial

What is this clinical trial studying?

An observational study of Gestational Diabetes and Pregnancy Related, run by Northwestern University at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gestational diabetes (GDM) (time frame: When participants are between 24 weeks 0 days pregnant to 28 weeks 0 days pregnant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04860336, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in