Early Detection of Gestational Diabetes Mellitus in Pregnancy

University of Massachusetts, Worcester80 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

SINGLE

Enrollment

Conditions

Gestational Diabetes Mellitus in Pregnancy Pregnancy, High Risk

Interventions

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

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, United States

RECRUITING

Outcomes

Primary Outcomes

Gestational Diabetes Mellitus

Confirmed diagnosis of GDM based on 3 hour 100 gram glucose tolerance test

Time frame: In pregnancy (24-28 weeks gestation)

Secondary Outcomes

Mode of Delivery

Mode of delivery (Vaginal versus Cesarean 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

APGAR Score (range 0 to 10, with 10 being the best)

Time frame: At Birth

Neonatal Intensive Care Unit Admission

Admission to Level 2 or greater neonatal ICU and length of stay

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

This will be assessed by the Patient Satisfaction Survey questionnaire, which is scored out of 30, with 30 being the highest score)

Central Contacts

Gianna L Wilkie, MD

CONTACT

77743642523 Gianna.Wilkie@umassmemorial.org

Data from ClinicalTrials.gov

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