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.
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
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.
- Conditions
- Gestational Diabetes, Pregnancy Related
- 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 group | Role | What they receive |
|---|---|---|
| Pregnant women less than or equal to 14w0d gestation | Not described Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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)
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
Cesarean delivery
Secondary outcome in GO MOMs mothers: Number of mothers with cesarean delivery
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start1 Apr 2021
- Primary completion9 Jun 2025
- Study completion18 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Yale University, Women and Infants Hospital of Rhode Island, University of Pittsburgh, Massachusetts General Hospital, Tufts Medical Center, Columbia University, Kaiser Permanente
- Responsible party
- Principal investigator, Denise Scholtens, Northwestern University
- Investigators
- Denise Scholtens, PhD, Principal investigator, Northwestern University
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycemic Observation and Metabolic Outcomes in Mothers and Offspring / Glycemic Profile of Pregnancy Consortium
- ClinicalTrials.gov ID
- NCT04860336
- Acronym / sponsor ID
- GO MOMs / GO MOMs
- Conditions
- Gestational Diabetes, Pregnancy Related
- Keywords
- gestational diabetes, continuous glucose monitor, oral glucose tolerance test, gestational diabetes mellitus, GDM, OGTT, CGM, glucose tolerance test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,179 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Yale University, Women and Infants Hospital of Rhode Island, University of Pittsburgh, Massachusetts General Hospital, Tufts Medical Center, Columbia University, Kaiser Permanente
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 9 Jun 2025 (actual)
- Study completion
- 18 Jul 2025 (actual)
- First posted
- 26 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women less than or equal to 14w0d gestation | – | Other: Observational |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant adults who enroll prior to 10w0d-14w0d gestation.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalObservational | Other | Pregnant women less than or equal to 14w0d gestation |
Primary outcome
Gestational diabetes (GDM)
Time frame: When participants are between 24 weeks 0 days pregnant to 28 weeks 0 days pregnant
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).
Large for gestational age (LGA)
Time frame: Delivery
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.
20 secondary outcomes
Hypertension
Time frame: Evaluated 30-90 days after delivery through chart abstraction for any events occurring during pregnancy
Cesarean delivery
Time frame: Delivery
Sum of skinfolds
Time frame: Within 72 hours after delivery
Small for gestational age (SGA)
Time frame: Delivery
Preterm birth
Time frame: Delivery
Shoulder dystocia
Time frame: Delivery
Neonatal birth injury
Time frame: Delivery
Neonatal hypoglycemia
Time frame: Within 30 days after delivery
Neonatal respiratory morbidity
Time frame: Within 30 days after delivery
Neonatal hyperbilirubinemia
Time frame: Within 30 days after delivery
Nutrition Substudy: Mean CGM glucose 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
Time frame: When participants are between 24 weeks 0 days pregnant to 28 weeks 0 days pregnant
Nutrition Substudy: Mean nocturnal glucose
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
Time frame: When participants are between 16 weeks 0 days pregnant to 36 weeks 0 days pregnant
Nutrition Substudy: Insulin resistance
Time frame: When participants are between 24 weeks 0 days pregnant to 28 weeks 0 days pregnant
Nutrition Substudy: Insulin secretory response
Time frame: When participants are between 24 weeks 0 days pregnant to 28 weeks 0 days pregnant
Nutrition Substudy: gestational diabetes mellitus diagnosis
Time frame: When participants are between 24 weeks 0 days pregnant to 28 weeks 0 days pregnant
Nutrition Substudy: Neonatal fat mass
Time frame: Within 72 hours of delivery
Nutrition Substudy: large for gestational age birthweight
Time frame: Delivery
Nutrition Substudy: Birthweight for gestational age percentile
Time frame: Delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Derived from this study: PubMed 38851233GO 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.
- Information about the studyLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Participants have the option to agree to share dataset with National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Repository.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denise Scholtens, PhD principal investigator
Northwestern University
9 sites in 1 country: see every site and its status.
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.