Early Detection of Gestational Diabetes Mellitus in Pregnancy

Official title

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

Overview

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.

Interventions

• 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.
• 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.

Primary outcome measures

• Gestational Diabetes Mellitus [Time frame: In pregnancy (24-28 weeks gestation)]

Secondary outcome measures (8)

• Mode of 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 [Time frame: At Birth]
• Neonatal Intensive Care Unit Admission [Time frame: At delivery and within first 2 days of life]
• Gestational Age at Delivery [Time frame: At Birth]
• Patient Satisfaction with Diabetes Screening Method [Time frame: Postpartum day 1 after birth]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Screening

Study locations

United States · 1 center

• University of Massachusetts Memorial Medical Center — Worcester

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. PMID 29898442
• 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. PMID 21268030

Identifiers

NCT: NCT05388643 · STUDY00002047 · K23HD111526

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗