University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01605, United States
Location status: Recruiting
NCT Number: NCT05388643
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).
Interested in participating?
Request Info18 year and older
Female
Interventional
Not applicable
Worcester, Massachusetts, 01605, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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
Time frame: In pregnancy (24-28 weeks gestation)
Confirmed diagnosis of GDM based on 3 hour 100 gram glucose tolerance test
Time frame: At Birth
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 (range 0 to 10, with 10 being the best)
Time frame: At delivery and within first 2 days of life
Admission to Level 2 or greater neonatal ICU and length of stay
Time frame: At Birth
Gestational Age at Delivery
Time frame: 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)
Contact information is provided by the study sponsor or research team.
University of Massachusetts, Worcester
Other
Early Detection of Gestational Diabetes Mellitus in Pregnancy: A Randomized Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06963528
Birth Hypoxia, Birth Outcome, Adverse
Oxford, United Kingdom
View Trial DetailsNCT07551011
Behavior, Behavior, Animal
Lahore, Punjab Province, Pakistan
View Trial DetailsNCT07565727
Cardiometabolic Diseases, Diabetes Mellitus
Knoxville, Tennessee, United States
View Trial DetailsNCT06548828
Behavior, Breast Feeding
Washington D.C., District of Columbia, United States
View Trial Details