Large for Gestational Age (LGA)NCT07708129
Repeat Late GDM Testing and Cesarean Delivery Rates
A study testing Glucose tolerance test and continuous glucose monitor in people with Large for Gestational Age (LGA) and Pregnancy, run by Shauna F. Williams, MD.
Trial summary
The goal of this randomized trial is determine if re-testing for gestational diabetes in the third trimester after an ultrasound measurement of estimated fetal weight (EFW) or abdominal circumference greater than 90%ile decreases cesarean delivery rate, and to evaluate the optimal method of re-testing. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Large for Gestational Age (LGA), Pregnancy
- What is being tested?
- Glucose tolerance test and continuous glucose monitor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 31 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Gestational age 30 weeks 0 days and 36 weeks 6 days
- Ultrasound with estimated fetal weight or abdominal circumference greater than 90th%ile
- Age 18-50 years old.
Who cannot join
- Previously diagnosed gestational diabetes or pre-gestational diabetes
- Multiple gestation
- Previous cesarean delivery
- Any condition precluding vaginal delivery (placenta previa/placenta accreta spectrum disorders, vasa previa, prior uterine surgery with contraindication to vaginal delivery)
- Suboptimal dating (based on US >22wk gestation)
- Contraindication to glucose tolerance test
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Impact of Late Gestational Diabetes Detection and Treatment on Cesarean Delivery Rates After Negative Initial Screening
The goal of this randomized trial is determine if re-testing for gestational diabetes in the third trimester after an ultrasound measurement of estimated fetal weight (EFW) or abdominal circumference greater than 90%ile decreases cesarean delivery rate, and to evaluate the optimal method of re-testing. The main question it aims to answer is:
Does repeat testing for gestational diabetes and management of hyperglycemia decrease the cesarean delivery rate in fetuses measuring >90%ile by estimated fetal weight (EFW) or abdominal circumference (AC) on ultrasound in the third trimester.
Participants will be randomized into two groups: Group 1 will undergo a repeat glucose tolerance test (GTT) with blinded continuous glucose monitor (CGM) and group 2 will have no intervention. Participants in group 1 will receive nutrition counseling as this would be standard in patients at high risk for gestational diabetes.
Read the detailed description
This will be a prospective randomized control trial to determine if re-testing for gestational diabetes in the third trimester after an ultrasound measurement of estimated fetal weight (EFW) or abdominal circumference greater than 90%ile decreases cesarean delivery rate, and to evaluate the optimal method of re-testing. Pregnant women will be recruited with gestational age between 30 weeks and 36 weeks gestation with an ultrasound that demonstrates a fetus with either estimated fetal weight (EFW) >90%, abdominal circumference (AC)>90% or both. They will be randomized into two groups: Group 1 will undergo a repeat glucose tolerance test (GTT) with blinded continuous glucose monitor (CGM) and group 2 will have no intervention. Participants in group 1 will receive nutrition counseling as this would be standard in patients at high risk for gestational diabetes.
The primary outcome is cesarean delivery. Labor course, complications, and delivery/neonatal data will be obtained.
- Conditions
- Large for Gestational Age (LGA), Pregnancy
- Being tested
- Glucose tolerance test and continuous glucose monitor
- Keywords
- Large for gestational age, Ultrasound, Pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucose tolerance test and continuous glucose monitorDiagnostic test
- Glucose tolerance test
- Continuous glucose monitoring for two weeks
- Nutrition counseling
| Study group | Role | What they receive |
|---|---|---|
| Repeat glucose tolerance test (GTT) with continuous glucose monitor | Experimental | Group 1 will undergo a repeat glucose tolerance test (GTT) with blinded continuous glucose monitor (CGM). Patients will receive nutrition counseling as this would be standard in patients at high risk for gestational diabetes. The CGM sensor will collect glycemic data over 10 consecutive days, with up to 20 days of CGM data per patient, ie they will wear two 10-day CGMs in total. The patients in group 1, as well as the researchers and the patient's provider will know the patient is wearing a CGM, however the CGM data will be blinded until the patient delivers. Receives: Diagnostic Test: Glucose tolerance test and continuous glucose monitor |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of cesarean delivery
Measured: From enrollment until delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion30 Apr 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Large for Gestational Age (LGA)Studies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shauna F. Williams, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shauna F. Williams, MD, Rutgers, The State University of New Jersey
- Investigators
- Shauna Williams, MD, Principal investigator, Rutgers Health New Jersey Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07708129
- Sponsor's protocol ID
- Pro2026000906
- Status last verified
- Jul 2026
- First submitted
- 12 Jul 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data can be made available upon request.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Late Gestational Diabetes Detection and Treatment on Cesarean Delivery Rates After Negative Initial Screening
- ClinicalTrials.gov ID
- NCT07708129
- Acronym / sponsor ID
- Pro2026000906
- Conditions
- Large for Gestational Age (LGA), Pregnancy
- Keywords
- Large for gestational age, Ultrasound, Pregnancy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Shauna F. Williams, MDUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 16 Jul 2026 (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 trial is determine if re-testing for gestational diabetes in the third trimester after an ultrasound measurement of estimated fetal weight (EFW) or abdominal circumference greater than 90%ile decreases cesarean delivery rate, and to evaluate the optimal method of re-testing. The main question it aims to answer is:
Does repeat testing for gestational diabetes and management of hyperglycemia decrease the cesarean delivery rate in fetuses measuring >90%ile by estimated fetal weight (EFW) or abdominal circumference (AC) on ultrasound in the third trimester.
Participants will be randomized into two groups: Group 1 will undergo a repeat glucose tolerance test (GTT) with blinded continuous glucose monitor (CGM) and group 2 will have no intervention. Participants in group 1 will receive nutrition counseling as this would be standard in patients at high risk for gestational diabetes.
Detailed description
This will be a prospective randomized control trial to determine if re-testing for gestational diabetes in the third trimester after an ultrasound measurement of estimated fetal weight (EFW) or abdominal circumference greater than 90%ile decreases cesarean delivery rate, and to evaluate the optimal method of re-testing. Pregnant women will be recruited with gestational age between 30 weeks and 36 weeks gestation with an ultrasound that demonstrates a fetus with either estimated fetal weight (EFW) >90%, abdominal circumference (AC)>90% or both. They will be randomized into two groups: Group 1 will undergo a repeat glucose tolerance test (GTT) with blinded continuous glucose monitor (CGM) and group 2 will have no intervention. Participants in group 1 will receive nutrition counseling as this would be standard in patients at high risk for gestational diabetes.
The primary outcome is cesarean delivery. Labor course, complications, and delivery/neonatal data will be obtained.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Repeat glucose tolerance test (GTT) with continuous glucose monitor | Experimental | Diagnostic Test: Glucose tolerance test and continuous glucose monitorGroup 1 will undergo a repeat glucose tolerance test (GTT) with blinded continuous glucose monitor (CGM). Patients will receive nutrition counseling as this would be standard in patients at high risk for gestational diabetes. The CGM sensor will collect glycemic data over 10 consecutive days, with up to 20 days of CGM data per patient, ie they will wear two 10-day CGMs in total. The patients in group 1, as well as the researchers and the patient's provider will know the patient is wearing a CGM, however the CGM data will be blinded until the patient delivers. |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Gestational age 30 weeks 0 days and 36 weeks 6 days
- Ultrasound with estimated fetal weight or abdominal circumference greater than 90th%ile
- Age 18-50 years old.
Key exclusion criteria (6 listed)
- Previously diagnosed gestational diabetes or pre-gestational diabetes
- Multiple gestation
- Previous cesarean delivery
- Any condition precluding vaginal delivery (placenta previa/placenta accreta spectrum disorders, vasa previa, prior uterine surgery with contraindication to vaginal delivery)
- Suboptimal dating (based on US >22wk gestation)
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 |
|---|---|---|
| Glucose tolerance test and continuous glucose monitor1. Glucose tolerance test 2. Continuous glucose monitoring for two weeks 3. Nutrition counseling | Diagnostic test | Repeat glucose tolerance test (GTT) with continuous glucose monitor |
Primary outcome
Rate of cesarean delivery
Time frame: From enrollment until delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: Yes. Deidentified data can be made available upon request.
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Fetal Clavicular Measurement to Predict Fetal Macrosomia
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Effects of Lifestyle Intervention on Childhood Outcomes in LGA Infants
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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.
Shauna Williams, MD principal investigator
Rutgers Health New Jersey Medical School
Questions about this trial
What is this clinical trial studying?
A study testing Glucose tolerance test and continuous glucose monitor in people with Large for Gestational Age (LGA) and Pregnancy, run by Shauna F. Williams, MD.
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 3 inclusion and 6 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: opening soon, as of the sponsor's last update on 16 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rebecca Bradley, DO (973-862-5262, rlb310@njms.rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of cesarean delivery (time frame: From enrollment until 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 16 Jul 2026.