Early Detection of Gestational Diabetes Mellitus in Pregnancy

Not Applicable

Not yet recruiting

• Conditions: Gestational Diabetes Mellitus in Pregnancy; Pregnancy, High Risk
• Interventions: Diagnostic Test: Routine Gestational Diabetes Screening; Diagnostic Test: Enhanced First Trimester GDM Screening

• Registration Number: NCT05388643
• Lead Sponsor: University of Massachusetts, Worcester

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).

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 Timeline

• Study First Submitted: 2022-05-18
• Study First Submitted QC: 2022-05-18
• Study First Posted: 2022-05-24
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-04
• Last Update Posted: 2025-05-06
• Study Start: 2025-07-01
• Primary Completion: 2026-12-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care GDM Screening	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.
Enhanced First Trimester GDM Screening	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Neonatal Birthweight	At Birth	Neonatal Birthweight
Number of participants with brachial plexus injury	At Birth	Number of participants with brachial plexus injury
APGAR Score	At Birth	APGAR Score (range 0 to 10, with 10 being the best)
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
Mode of Delivery	At Birth	Mode of delivery (Vaginal versus Cesarean delivery)
Gestational Age at Delivery	At Birth	Gestational Age at Delivery
Number of Participants with Shoulder Dystocia	At Birth	Number of Participants with Shoulder Dystocia
Patient Satisfaction with Diabetes Screening Method	Postpartum day 1 after birth	This will be assessed by the Patient Satisfaction Survey questionnaire, which is scored out of 30, with 30 being the highest score)

Trial Locations

Locations (1)

University of Massachusetts Memorial Medical Center; 🇺🇸 Worcester, Massachusetts, United States