Early Detection of Gestational Diabetes Mellitus in Pregnancy

Sponsor

University of Massachusetts, Worcester (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05388643

Collaborator

(none)

Enrollment

Location

Arms

17.1

Anticipated Duration (Months)

4.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Gestational Diabetes Mellitus in Pregnancy Pregnancy, High Risk	Diagnostic Test: Enhanced First Trimester GDM Screening Diagnostic Test: Routine Gestational Diabetes Screening	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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 (Outcomes Assessor)

Masking Description:

Those assessing the outcomes from the medical chart will be blinded to the randomization process and the assigned study arm. Patients, the primary investigator, and their care providers will be aware of their treatment status.

Primary Purpose:

Screening

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Enhanced First Trimester GDM Screening 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 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.
Active Comparator: Standard of Care GDM 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.	Diagnostic Test: Routine Gestational Diabetes 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. Other Names: Third Trimester Screening

Arm

Intervention/Treatment

Experimental: Enhanced First Trimester GDM Screening

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

Active Comparator: Standard of Care GDM 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.

Diagnostic Test: Routine Gestational Diabetes Screening

Other Names:

Third Trimester Screening

Outcome Measures

Primary Outcome Measures

Gestational Diabetes Mellitus [In pregnancy (24-28 weeks gestation)]
Confirmed diagnosis of GDM based on 3 hour 100 gram glucose tolerance test

Secondary Outcome Measures

Mode of Delivery [At Birth]
Mode of delivery (Vaginal versus Cesarean delivery)
Neonatal Birthweight [At Birth]
Neonatal Birthweight
Number of Participants with Shoulder Dystocia [At Birth]
Number of Participants with Shoulder Dystocia
Number of participants with brachial plexus injury [At Birth]
Number of participants with brachial plexus injury
APGAR Score [At Birth]
APGAR Score
Neonatal Intensive Care Unit Admission [At delivery and within first 2 days of life]
Admission to Level 2 or greater neonatal ICU and length of stay
Gestational Age at Delivery [At Birth]
Gestational Age at Delivery
Patient Satisfaction with Diabetes Screening Method [Postpartum day 1 after birth]
This will be assessed by the Patient Satisfaction Survey questionnaire.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

1. age greater than or equal to 18 years old,
1. singleton gestation less than or equal to 12 weeks at initial obstetric visit,
1. receiving prenatal care at UMMHC and plans to deliver at UMMHC,
1. able and willing to provide informed consent,
1. English or Spanish speaking, and
1. are at high risk for developing GDM by ACOG clinical risk factor guidelines.

Exclusion Criteria:

1. known diagnosis of pre-existing pregestational diabetes,
1. plan to receive prenatal care or deliver outside of UMMHC,
1. inability to complete oral glucose tolerance test (e.g. gastric bypass surgery history, gastric dumping syndrome history, vomiting of oral glucose tolerance test), or
1. systemic steroid use.