Early Detection of Gestational Diabetes Mellitus in Pregnancy

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Pregnancy, High Risk; Gestational Diabetes Mellitus in Pregnancy
• Intervention / Treatment: Diagnostic test: Enhanced First Trimester GDM Screening; Diagnostic test: Routine Gestational Diabetes Screening

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 Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gianna L Wilkie, MD; Phone Number: 77743642523; Email: Gianna.Wilkie@umassmemorial.org

Study Locations

• United States
  • Massachusetts
    • Worcester, Massachusetts, United States, 01605
      • University of Massachusetts Memorial Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Massachusetts, Worcester
• Investigators: Principal Investigator: Gianna Wilkie, MD, University of Massachusetts Chan Medical School

Publications and helpful links

General Publications

• Sweeting AN, Wong J, Appelblom H, Ross GP, Kouru H, Williams PF, Sairanen M, Hyett JA. A Novel Early Pregnancy Risk Prediction Model for Gestational Diabetes Mellitus. Fetal Diagn Ther. 2019;45(2):76-84. doi: 10.1159/000486853. Epub 2018 Jun 13.
• Nanda S, Savvidou M, Syngelaki A, Akolekar R, Nicolaides KH. Prediction of gestational diabetes mellitus by maternal factors and biomarkers at 11 to 13 weeks. Prenat Diagn. 2011 Feb;31(2):135-41. doi: 10.1002/pd.2636. Epub 2010 Dec 28.

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: May 18, 2022
• First Submitted That Met QC Criteria: May 18, 2022
• First Posted (Actual): May 24, 2022

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Pregnancy; Screening; Gestational Diabetes; Neonatal Outcomes; Maternal Outcomes
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Diabetes, Gestational; Pregnancy in Diabetics
• Other Study ID Numbers: STUDY00000390

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes