Gestational DiabetesEARLYGDMNCT06190405
Universal Hemoglobin A1c Versus Risk-based Screening for Early Gestational Diabetes Mellitus (EARLY GDM): A Randomized Controlled Trial
A study testing Hemoglobin A1c and Risk-based screening by ACOG with two-step GTT in people with Gestational Diabetes and Large for Gestational Age, run by Thomas Jefferson University.
Trial summary
The goal of this randomized controlled trial is to compare the rate of large-for-gestational-age neonates between universal screening with glycated hemoglobin (A1C) and early risk-based screening with a glucose tolerance test (GTT) among pregnancies that present to prenatal care at <16 weeks 6 days. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Gestational Diabetes, Large for Gestational Age
- What is being tested?
- Hemoglobin A1c and Risk-based screening by ACOG with two-step GTT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 770 participants
- Where
- No sites listed yet
- Study dates
- Jan 2024to Jun 2025
- Phase
- Interventional
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Presenting to prenatal care ≤16 6/7 weeks of gestation
- Intend to deliver at TJUH
Who cannot join
- Multifetal gestation
- Pre-pregnancy diagnosis of diabetes mellitus
- History of malabsorptive gastric bypass surgery
- Hemoglobinopathy
Trial locations and contacts
No sites are listed yet.
About this study
The goal of this randomized controlled trial is to compare the rate of large-for-gestational-age neonates between universal screening with glycated hemoglobin (A1C) and early risk-based screening with a glucose tolerance test (GTT) among pregnancies that present to prenatal care at <16 weeks 6 days.
- Conditions
- Gestational Diabetes, Large for Gestational Age
- Being tested
- Hemoglobin A1c, Risk-based screening by ACOG with two-step GTT
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemoglobin A1cDiagnostic test
Patients with a HbA1c <5.7% will be considered a normal test, and they will continue their routine prenatal care, including GDM screening at 24-28 weeks. Patients with a HbA1c ≥5.7% and ≤6.4% will be diagnosed with early GDM. Patients with a HbA1c ≥6.5% will be diagnosed with pregestational diabetes. Patient diagnosed with early GDM or pregestational diabetes will be treated as per usual clinical protocol for gestational/pregestational diabetes.
Risk-based screening by ACOG with two-step GTTDiagnostic test
Patients will be assessed for risk factors for GDM as per ACOG. Patients with a negative screen will continue routine care, including GDM screening at 24-28 weeks. Patients with a positive screen will undergo a two-step GTT screening. Patients with a 1-h GTT <135 mg/dL will continue with routine care, including GDM screening at 24-28 weeks. Patients with a 1-h GTT ≥185 mg/dL and <200 mg/dL will be diagnosed with early GDM. Patients with a 1-h GTT ≥200 mg/dL will be diagnosed with pregestational DM. Patients with a 1-h GTT ≥135 mg/dL and <185 mg/dL will undergo a fasting 3-h GTT. Patient will be diagnosed with early GDM by Carpenter and Coustan criteria. Patients will be diagnosed with pregestational DM if their fasting glucose value is ≥126 mg/dL. If patients pass the 3-h GTT, they will continue routine care, including GDM screen at 24-28 weeks with a 3-h GTT. Patient diagnosed with early GDM/pregestational DM will be treated as per usual clinical protocol for GDM/pregestational DM.
| Study group | Role | What they receive |
|---|---|---|
| Universal hemoglobin A1c | Experimental | Patients at <16 weeks will have a hemoglobin A1c obtained Receives: Diagnostic Test: Hemoglobin A1c |
| Risk-based screening by ACOG with two-step GTT | Active comparator | Patients at <16 weeks will be assessed for risk factors for diabetes as described by ACOG. If patients meet criteria, they will be screened with two-step screening for gestational diabetes. If patients do not meet criteria, they will not be screened until the routine timing of screening for gestational diabetes. Receives: Diagnostic Test: Risk-based screening by ACOG with two-step GTT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Large-for-gestational age
Birthweight ≥90th percentile
Measured: At time of delivery
Secondary outcomes (11)
Preterm birth
Measured: At time of delivery
Stillbirth
Fetal death prior to delivery
Measured: At time of delivery
Shoulder dystocia
Measured: At time of delivery
Birth injury
Measured: At time of delivery
Neonatal hypoglycemia
Measured: From 0 to 24 hours after birth
Neonatal death
Neonatal death within 28 days of birth
Measured: 28 days after birth
Rate of early GDM diagnosis
Measured: At time of delivery
Rate of GDM diagnosis after 24 weeks
Measured: At time of delivery
Rate of pregestational diabetes
Measured: At time of delivery
Rate of patients requiring medication
Patients requiring oral hypoglycemic medication and/or insulin treatment
Measured: At time of delivery
Rate of hypertensive disorders of pregnancy
Gestational hypertension and/or preeclampsia
Measured: At time of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study startJan 2024 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 770 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodney McLaren, Jr., Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06190405
- Sponsor's protocol ID
- iRISID-2023-1750
- Acronym
- EARLYGDM
- Status last verified
- Dec 2023
- First submitted
- 19 Dec 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Universal Hemoglobin A1c Versus Risk-based Screening for Early Gestational Diabetes Mellitus (EARLY GDM): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06190405
- Acronym / sponsor ID
- EARLYGDM / iRISID-2023-1750
- Conditions
- Gestational Diabetes, Large for Gestational Age
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 770 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 5 Jan 2024 (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 goal of this randomized controlled trial is to compare the rate of large-for-gestational-age neonates between universal screening with glycated hemoglobin (A1C) and early risk-based screening with a glucose tolerance test (GTT) among pregnancies that present to prenatal care at <16 weeks 6 days.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Universal hemoglobin A1c | Experimental | Diagnostic Test: Hemoglobin A1cPatients at <16 weeks will have a hemoglobin A1c obtained |
| Risk-based screening by ACOG with two-step GTT | Active comparator | Diagnostic Test: Risk-based screening by ACOG with two-step GTTPatients at <16 weeks will be assessed for risk factors for diabetes as described by ACOG. If patients meet criteria, they will be screened with two-step screening for gestational diabetes. If patients do not meet criteria, they will not be screened until the routine timing of screening for gestational diabetes. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Presenting to prenatal care ≤16 6/7 weeks of gestation
- Intend to deliver at TJUH
Key exclusion criteria (4 listed)
- Multifetal gestation
- Pre-pregnancy diagnosis of diabetes mellitus
- History of malabsorptive gastric bypass surgery
- Hemoglobinopathy
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 |
|---|---|---|
| Hemoglobin A1cPatients with a HbA1c <5.7% will be considered a normal test, and they will continue their routine prenatal care, including GDM screening at 24-28 weeks. Patients with a HbA1c ≥5.7% and ≤6.4% will be diagnosed with early GDM. Patients with a HbA1c ≥6.5% will be diagnosed with pregestational diabetes. Patient diagnosed with early GDM or pregestational diabetes will be treated as per usual clinical protocol for gestational/pregestational diabetes. | Diagnostic test | Universal hemoglobin A1c |
| Risk-based screening by ACOG with two-step GTTPatients will be assessed for risk factors for GDM as per ACOG. Patients with a negative screen will continue routine care, including GDM screening at 24-28 weeks. Patients with a positive screen will undergo a two-step GTT screening. Patients with a 1-h GTT <135 mg/dL will continue with routine care, including GDM screening at 24-28 weeks. Patients with a 1-h GTT ≥185 mg/dL and <200 mg/dL will be diagnosed with early GDM. Patients with a 1-h GTT ≥200 mg/dL will be diagnosed with pregestational DM. Patients with a 1-h GTT ≥135 mg/dL and <185 mg/dL will undergo a fasting 3-h GTT. Patient will be diagnosed with early GDM by Carpenter and Coustan criteria. Patients will be diagnosed with pregestational DM if their fasting glucose value is ≥126 mg/dL. If patients pass the 3-h GTT, they will continue routine care, including GDM screen at 24-28 weeks with a 3-h GTT. Patient diagnosed with early GDM/pregestational DM will be treated as per usual clinical protocol for GDM/pregestational DM. | Diagnostic test | Risk-based screening by ACOG with two-step GTT |
Primary outcome
Large-for-gestational age
Time frame: At time of delivery
Birthweight ≥90th percentile
11 secondary outcomes
Preterm birth
Time frame: At time of delivery
Stillbirth
Time frame: At time of delivery
Shoulder dystocia
Time frame: At time of delivery
Birth injury
Time frame: At time of delivery
Neonatal hypoglycemia
Time frame: From 0 to 24 hours after birth
Neonatal death
Time frame: 28 days after birth
Rate of early GDM diagnosis
Time frame: At time of delivery
Rate of GDM diagnosis after 24 weeks
Time frame: At time of delivery
Rate of pregestational diabetes
Time frame: At time of delivery
Rate of patients requiring medication
Time frame: At time of delivery
Rate of hypertensive disorders of pregnancy
Time frame: At time of delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Hemoglobin A1c and Risk-based screening by ACOG with two-step GTT in people with Gestational Diabetes and Large for Gestational Age, run by Thomas Jefferson University.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rodney McLaren, MD (215-955-5000, rodney.mclaren@jefferson.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Large-for-gestational age (time frame: At time of delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jan 2024.