Early Detection of Gestational Diabetes Mellitus in Pregnancy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Early Detection of Gestational Diabetes Mellitus in Pregnancy: A Randomized Trial

Conditions
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Gestational Diabetes Mellitus in Pregnancy, Pregnancy, High Risk

Intervention / Treatment
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* Diagnostic Test: Enhanced First Trimester GDM Screening
* Diagnostic Test: Routine Gestational Diabetes Screening


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enhanced First Trimester GDM Screening<br>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. | Diagnostic Test: Enhanced First Trimester GDM Screening<br>* 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.<br>|
| Active Comparator: Standard of Care GDM Screening<br>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. | Diagnostic Test: Routine Gestational Diabetes Screening<br>* 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.<br>* Other names: Third Trimester Screening;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational Diabetes Mellitus | Confirmed diagnosis of GDM based on 3 hour 100 gram glucose tolerance test | In pregnancy (24-28 weeks gestation) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mode of Delivery | Mode of delivery (Vaginal versus Cesarean delivery) | At Birth | 
| Neonatal Birthweight | Neonatal Birthweight | At Birth | 
| Number of Participants with Shoulder Dystocia | Number of Participants with Shoulder Dystocia | At Birth | 
| Number of participants with brachial plexus injury | Number of participants with brachial plexus injury | At Birth | 
| APGAR Score | APGAR Score (range 0 to 10, with 10 being the best) | At Birth | 
| Neonatal Intensive Care Unit Admission | Admission to Level 2 or greater neonatal ICU and length of stay | At delivery and within first 2 days of life | 
| Gestational Age at Delivery | Gestational Age at Delivery | 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) | Postpartum day 1 after birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, Gestational Diabetes, Screening, Maternal Outcomes, Neonatal Outcomes