Gestational Diabetes Mellitus in PregnancyNCT05388643
Early Detection of Gestational Diabetes Mellitus in Pregnancy
A study testing Enhanced First Trimester GDM Screening and Routine Gestational Diabetes Screening in people with Gestational Diabetes Mellitus in Pregnancy and Pregnancy, High Risk, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
The purpose of this study is to develop an implementation protocol and test the feasibility and acceptability of a first trimester screening protocol for the early detection of gestational diabetes mellitus (GDM). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Diabetes Mellitus in Pregnancy, Pregnancy, High Risk
- What is being tested?
- Enhanced First Trimester GDM Screening and Routine Gestational Diabetes Screening
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2025to 1 Dec 2026
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) age greater than or equal to 18 years old,
- 2) singleton gestation less than or equal to 12 weeks at initial obstetric visit,
- 3) receiving prenatal care at UMMHC and plans to deliver at UMMHC,
- 4) able and willing to provide informed consent,
- 5) English or Spanish speaking, and
- 6) are at high risk for developing GDM by ACOG clinical risk factor guidelines.
Who cannot join
- 1) known diagnosis of pre-existing pregestational diabetes,
- 2) plan to receive prenatal care or deliver outside of UMMHC,
- 3) inability to complete oral glucose tolerance test (e.g. gastric bypass surgery history, gastric dumping syndrome history, vomiting of oral glucose tolerance test), or
- 4) systemic steroid use.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01605
Gianna L Wilkie, MD, 508-334-4067, Gianna.Wilkie@umassmemorial.org
About this study
Official title: Early Detection of Gestational Diabetes Mellitus in Pregnancy: A Randomized Trial
The purpose of this study is to develop an implementation protocol and test the feasibility and acceptability of a first trimester screening protocol for the early detection of gestational diabetes mellitus (GDM).
Read the detailed description
Gestational diabetes mellitus (GDM) is an important contributor to both maternal and neonatal morbidity and mortality in pregnancy. GDM has lifelong complications including an increased risk of developing type 2 diabetes mellitus and cardiovascular disease for women, and their offspring are at higher risk of being obese and also having diabetes in childhood and adolescence. Approximately 1 in 8 pregnancies is impacted by gestational diabetes mellitus worldwide. First trimester GDM screening is varied due to conflicting national guidelines, and the best strategy is unknown. The goal of the proposed research is to develop an implementation protocol and test the feasibility and acceptability of a first trimester screening protocol for the early detection of GDM. The investigators will utilize a pilot randomized controlled trial to recruit 80 high-risk pregnant women in the first trimester, of whom half will receive protocolized early GDM screening with serum biomarkers before 12 weeks and the remaining half will receive the current standard of care with screening between 24 and 28 weeks of gestation with possible early screening based on provider discretion.
- Being tested
- Enhanced First Trimester GDM Screening, Routine Gestational Diabetes Screening
- Keywords
- Pregnancy, Gestational Diabetes, Screening, Maternal Outcomes, Neonatal Outcomes
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced First Trimester GDM ScreeningDiagnostic test
Women who are randomly assigned to this condition will be required to have early glucose screening with a prediction model composed of additional clinical risk factors and serum biomarkers (triglycerides, PAPP-A, and lipocalin-2) with their initial prenatal laboratory assessment.
Routine Gestational Diabetes ScreeningDiagnostic test
Also called Third Trimester Screening
Women who will be randomized to the comparison condition of usual standard of care will undergo routine standard of care. The standard of care will consist of routine screening for diabetes in pregnancy between 24 to 28 weeks of gestation via the two-step screening method with possible early screening with either plasma fasting glucose, oral glucose tolerance test, or hemoglobin A1c at the providers discretion to represent true clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced First Trimester GDM Screening | Experimental | Women who are randomly assigned to this condition will be required to have early glucose screening with a prediction model composed of additional clinical risk factors and serum biomarkers (triglycerides, PAPP-A, and lipocalin-2) with their initial prenatal laboratory assessment. Receives: Diagnostic Test: Enhanced First Trimester GDM Screening |
| Standard of Care GDM Screening | Active comparator | Women who will be randomized to the comparison condition of usual standard of care will undergo routine standard of care. The standard of care will consist of routine screening for diabetes in pregnancy between 24 to 28 weeks of gestation via the two-step screening method with possible early screening with either plasma fasting glucose, oral glucose tolerance test, or hemoglobin A1c at the providers discretion to represent true clinical practice. Receives: Diagnostic Test: Routine Gestational Diabetes Screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gestational Diabetes Mellitus
Confirmed diagnosis of GDM based on 3 hour 100 gram glucose tolerance test
Measured: In pregnancy (24-28 weeks gestation)
Secondary outcomes (8)
Mode of Delivery
Mode of delivery (Vaginal versus Cesarean delivery)
Measured: At Birth
Neonatal Birthweight
Neonatal Birthweight
Measured: At Birth
Number of Participants with Shoulder Dystocia
Number of Participants with Shoulder Dystocia
Measured: At Birth
Number of participants with brachial plexus injury
Number of participants with brachial plexus injury
Measured: At Birth
APGAR Score
APGAR Score (range 0 to 10, with 10 being the best)
Measured: At Birth
Neonatal Intensive Care Unit Admission
Admission to Level 2 or greater neonatal ICU and length of stay
Measured: At delivery and within first 2 days of life
Gestational Age at Delivery
Gestational Age at Delivery
Measured: At Birth
Patient Satisfaction with Diabetes Screening Method
This will be assessed by the Patient Satisfaction Survey questionnaire, which is scored out of 30, with 30 being the highest score)
Measured: Postpartum day 1 after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start1 Jul 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gestational Diabetes Mellitus in PregnancyStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, single-center, randomized study evaluating an early screening protocol for identifying women at high risk for developing GDM to the routine standard of care for GDM screening.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Gianna Wilkie, University of Massachusetts, Worcester
- Investigators
- Gianna Wilkie, MD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05388643
- Sponsor's protocol ID
- STUDY00002047
- Other IDs
- K23HD111526
- Status last verified
- Mar 2026
- First submitted
- 18 May 2022
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Sweeting AN, Wong J, Appelblom H, Ross GP, Kouru H, Williams PF, Sairanen M, Hyett JA. A Novel Early Pregnancy Risk Prediction Model for Gestational Diabetes Mellitus. Fetal Diagn Ther. 2019;45(2):76-84. doi: 10.1159/000486853. Epub 2018 Jun 13.
PubMed 29898442Nanda S, Savvidou M, Syngelaki A, Akolekar R, Nicolaides KH. Prediction of gestational diabetes mellitus by maternal factors and biomarkers at 11 to 13 weeks. Prenat Diagn. 2011 Feb;31(2):135-41. doi: 10.1002/pd.2636. Epub 2010 Dec 28.
PubMed 21268030
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Gestational Diabetes Mellitus in Pregnancy: A Randomized Trial
- ClinicalTrials.gov ID
- NCT05388643
- Acronym / sponsor ID
- STUDY00002047
- Keywords
- Pregnancy, Gestational Diabetes, Screening, Maternal Outcomes, Neonatal Outcomes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 24 May 2022 (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 purpose of this study is to develop an implementation protocol and test the feasibility and acceptability of a first trimester screening protocol for the early detection of gestational diabetes mellitus (GDM).
Detailed description
Gestational diabetes mellitus (GDM) is an important contributor to both maternal and neonatal morbidity and mortality in pregnancy. GDM has lifelong complications including an increased risk of developing type 2 diabetes mellitus and cardiovascular disease for women, and their offspring are at higher risk of being obese and also having diabetes in childhood and adolescence. Approximately 1 in 8 pregnancies is impacted by gestational diabetes mellitus worldwide. First trimester GDM screening is varied due to conflicting national guidelines, and the best strategy is unknown. The goal of the proposed research is to develop an implementation protocol and test the feasibility and acceptability of a first trimester screening protocol for the early detection of GDM. The investigators will utilize a pilot randomized controlled trial to recruit 80 high-risk pregnant women in the first trimester, of whom half will receive protocolized early GDM screening with serum biomarkers before 12 weeks and the remaining half will receive the current standard of care with screening between 24 and 28 weeks of gestation with possible early screening based on provider discretion.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a prospective, single-center, randomized study evaluating an early screening protocol for identifying women at high risk for developing GDM to the routine standard of care for GDM screening.
| Arm | Type | Receives |
|---|---|---|
| Enhanced First Trimester GDM Screening | Experimental | Diagnostic Test: Enhanced First Trimester GDM ScreeningWomen who are randomly assigned to this condition will be required to have early glucose screening with a prediction model composed of additional clinical risk factors and serum biomarkers (triglycerides, PAPP-A, and lipocalin-2) with their initial prenatal laboratory assessment. |
| Standard of Care GDM Screening | Active comparator | Diagnostic Test: Routine Gestational Diabetes ScreeningWomen who will be randomized to the comparison condition of usual standard of care will undergo routine standard of care. The standard of care will consist of routine screening for diabetes in pregnancy between 24 to 28 weeks of gestation via the two-step screening method with possible early screening with either plasma fasting glucose, oral glucose tolerance test, or hemoglobin A1c at the providers discretion to represent true clinical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1) age greater than or equal to 18 years old,
- 2) singleton gestation less than or equal to 12 weeks at initial obstetric visit,
- 3) receiving prenatal care at UMMHC and plans to deliver at UMMHC,
- 4) able and willing to provide informed consent,
- 5) English or Spanish speaking, and
Key exclusion criteria (4 listed)
- 1) known diagnosis of pre-existing pregestational diabetes,
- 2) plan to receive prenatal care or deliver outside of UMMHC,
- 3) inability to complete oral glucose tolerance test (e.g. gastric bypass surgery history, gastric dumping syndrome history, vomiting of oral glucose tolerance test), or
- 4) systemic steroid use.
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 |
|---|---|---|
| Enhanced First Trimester GDM ScreeningWomen who are randomly assigned to this condition will be required to have early glucose screening with a prediction model composed of additional clinical risk factors and serum biomarkers (triglycerides, PAPP-A, and lipocalin-2) with their initial prenatal laboratory assessment. | Diagnostic test | Enhanced First Trimester GDM Screening |
| Routine Gestational Diabetes ScreeningAlso: Third Trimester ScreeningWomen who will be randomized to the comparison condition of usual standard of care will undergo routine standard of care. The standard of care will consist of routine screening for diabetes in pregnancy between 24 to 28 weeks of gestation via the two-step screening method with possible early screening with either plasma fasting glucose, oral glucose tolerance test, or hemoglobin A1c at the providers discretion to represent true clinical practice. | Diagnostic test | Standard of Care GDM Screening |
Primary outcome
Gestational Diabetes Mellitus
Time frame: In pregnancy (24-28 weeks gestation)
Confirmed diagnosis of GDM based on 3 hour 100 gram glucose tolerance test
8 secondary outcomes
Mode of Delivery
Time frame: At Birth
Neonatal Birthweight
Time frame: At Birth
Number of Participants with Shoulder Dystocia
Time frame: At Birth
Number of participants with brachial plexus injury
Time frame: At Birth
APGAR Score
Time frame: At Birth
Neonatal Intensive Care Unit Admission
Time frame: At delivery and within first 2 days of life
Gestational Age at Delivery
Time frame: At Birth
Patient Satisfaction with Diabetes Screening Method
Time frame: Postpartum day 1 after birth
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 6 Apr 2026.
- Results publication: PubMed 29898442Sweeting AN, Wong J, Appelblom H, Ross GP, Kouru H, Williams PF, Sairanen M, Hyett JA. A Novel Early Pregnancy Risk Prediction Model for Gestational Diabetes Mellitus. Fetal Diagn Ther. 2019;45(2):76-84. doi: 10.1159/000486853. Epub 2018 Jun 13.
- Results publication: PubMed 21268030Nanda S, Savvidou M, Syngelaki A, Akolekar R, Nicolaides KH. Prediction of gestational diabetes mellitus by maternal factors and biomarkers at 11 to 13 weeks. Prenat Diagn. 2011 Feb;31(2):135-41. doi: 10.1002/pd.2636. Epub 2010 Dec 28.
- Individual participant dataSharing planned: No
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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.
Gianna Wilkie, MD principal investigator
University of Massachusetts, Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced First Trimester GDM Screening and Routine Gestational Diabetes Screening in people with Gestational Diabetes Mellitus in Pregnancy and Pregnancy, High Risk, run by University of Massachusetts, Worcester at 1 site 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 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: looking for participants now, as of the sponsor's last update on 6 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 1 site 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?
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 Gianna L Wilkie, MD (77743642523, Gianna.Wilkie@umassmemorial.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gestational Diabetes Mellitus (time frame: In pregnancy (24-28 weeks gestation)). 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 NCT05388643, which also lists 2 linked publications.
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 6 Apr 2026.