Early Detection of Gestational Diabetes Mellitus in Pregnancy

University of Massachusetts, Worcester

Status: Begins enrollment this month

Conditions: Gestational Diabetes Mellitus in Pregnancy; Pregnancy, High Risk

Treatments: Diagnostic Test: Enhanced First Trimester GDM Screening; Diagnostic Test: Routine Gestational Diabetes Screening

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05388643

STUDY00000390

K23HD111526 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 80 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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 design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Enhanced First Trimester GDM Screening

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Enhanced First Trimester GDM Screening

Standard of Care GDM Screening

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: Routine Gestational Diabetes Screening