Early Detection of Gestational Diabetes Mellitus in Pregnancy

Status Not yet recruiting

Clinical Trial 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).

Clinical Trial 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

Related Conditions & MeSH terms

Diabetes Mellitus
Diabetes, Gestational
Gestational Diabetes Mellitus in Pregnancy
Pregnancy in Diabetics
Pregnancy, High Risk

Clinical Trial Details

NCT number	NCT05388643
Study type	Interventional
Source	University of Massachusetts, Worcester
Contact	Gianna L Wilkie, MD
Phone	77743642523
Email	Gianna.Wilkie@umassmemorial.org
Status	Not yet recruiting
Phase	N/A
Start date	October 1, 2024
Completion date	December 1, 2025

View Details

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