Gestational Diabetes Mellitus in Pregnancy, Pregnancy, High Risk
Conditions
Keywords
Pregnancy, Gestational Diabetes, Screening, Maternal Outcomes, Neonatal Outcomes
Brief 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).
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_TESTEnhanced 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_TESTRoutine 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.
Sponsors
University of Massachusetts, Worcester
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Outcomes Assessor)
Masking description
Those assessing the outcomes from the medical chart will be blinded to the randomization process and the assigned study arm. Patients, the primary investigator, and their care providers will be aware of their treatment status.
Intervention model description
This is a prospective, single-center, randomized study evaluating an early screening protocol for identifying women at high risk for developing GDM to the routine standard of care for GDM screening.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gestational Diabetes Mellitus | In pregnancy (24-28 weeks gestation) | Confirmed diagnosis of GDM based on 3 hour 100 gram glucose tolerance test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mode of Delivery | At Birth | Mode of delivery (Vaginal versus Cesarean delivery) |
| Neonatal Birthweight | At Birth | Neonatal Birthweight |
| Number of Participants with Shoulder Dystocia | At Birth | Number of Participants with Shoulder Dystocia |
| Number of participants with brachial plexus injury | At Birth | Number of participants with brachial plexus injury |
| APGAR Score | At Birth | APGAR Score (range 0 to 10, with 10 being the best) |
| Neonatal Intensive Care Unit Admission | At delivery and within first 2 days of life | Admission to Level 2 or greater neonatal ICU and length of stay |
| Gestational Age at Delivery | At Birth | Gestational Age at Delivery |
| Patient Satisfaction with Diabetes Screening Method | 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) |
Countries
United States
Contacts
CONTACTGianna L Wilkie, MD
PRINCIPAL_INVESTIGATORGianna Wilkie, MD
University of Massachusetts Chan Medical School
Outcome results
None listed