Status
Conditions
Treatments
Study type
Funder types
Identifiers
About
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).
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
80 participants in 2 patient groups
Loading...
Central trial contact
Gianna L Wilkie, MD
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal