Preventing T2DM After GDM With Immediate Postpartum Screening
- Conditions
- Gestational DiabetesType 2 Diabetes
- Interventions
- Other: Active Comparator
- Registration Number
- NCT06457139
- Lead Sponsor
- University of Massachusetts, Worcester
- Brief Summary
The overall goal of this proposal is to create and test an implementation protocol for in-hospital immediate postpartum diabetes screening for postpartum patients with pregnancies affected by GDM.
- Detailed Description
Gestational diabetes mellitus (GDM) affects 6 to 8% of U.S. pregnancies annually and upwards of 1 in every 8 pregnancies worldwide. Pregnant individuals with GDM have higher rates of hypertensive disorders of pregnancy, cesarean delivery, and maternal mortality as compared to those without GDM. While GDM frequently resolves after delivery, up to 70% of patients will develop type 2 diabetes mellitus (T2DM) later in life10 and one third will develop subsequent diabetes or impaired glucose metabolism at the time of postpartum screening.
While postpartum screening is recommended by the American College of Obstetricians and Gynecologists (ACOG) and the American Diabetes Association (ADA) between 4-12 weeks postpartum for all patients with GDM in pregnancy, nearly 40% of patients do not attend a postpartum visit. Attendance is even lower among populations with limited resources, contributing to health disparities.
To address this issue, immediate in-hospital postpartum glucose tolerance testing has been evaluated and found to yield diagnostic values comparable to postpartum screening with the advantage of \~100% adherence. However, 2 challenges remain: currently there is a lack of widespread clinical implementation of in-hospital immediate postpartum diabetes screening.
Therefore, the overall goal of this proposal is to randomize patients to early screening during their postpartum hospitalization versus at their 6 week postpartum visit (current standard of care).
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 116
- pregnancy complicated by GDM as diagnosed with traditional two step testing in the third trimester according to Carpenter-Coustan Criteria
- receiving prenatal care at UMASS Memorial and plans to deliver at UMASS Memorial
- able and willing to provide informed consent
- ability to complete immediate in hospital postpartum glucose testing
- have evidence of impaired glucose metabolism defined as fasting glucose value of ≥126 mg/dL or 2-hour glucose value of ≥200 mg/dL
- known diagnosis of pre-existing pre-gestational diabetes in pregnancy
- inability to complete oral glucose tolerance test (e.g. gastric bypass surgery history, gastric dumping syndrome history, vomiting of oral glucose tolerance test) in pregnancy or immediately postpartum
- systemic steroid use
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Metformin Treatment Postpartum Metformin Hydrochloride Subjects who are randomly assigned to this condition will be treated with metformin extended-release formulation (500 mg tablet administered orally daily with evening meal) and given the same educational materials given to patients in the comparison condition. Standard of Care Education Active Comparator Subjects randomized to the comparison condition will receive the usual standard of care. The standard of care will consist of administration of educational materials adapted from the American Diabetes Association that discusses healthy lifestyle behaviors and the increased risks of developing T2DM after a pregnancy complicated by GDM.
- Primary Outcome Measures
Name Time Method Detection of Type 2 Diabetes Mellitus At time of postpartum screening (postpartum day 1 or 6 week postpartum visit pending randomization arm) Detection of Type 2 Diabetes Mellitus by 2 hour oral glucose tolerance test
Glycemic Outcomes--Hemoglobin A1c at time of postpartum screening (postpartum day 1 or 6 week postpartum visit pending randomization arm) Serum blood measurement of hemoglobin A1c
- Secondary Outcome Measures
Name Time Method Patient Satisfaction At postpartum visit (6 weeks after delivery) Participant satisfaction will be assessed using the validated survey, the Patient Satisfaction Survey. The survey was developed in 1979 and has been used to assess patient satisfaction with research participation based on 8 simple questions. It has not been used in a randomized trial in an obstetric population but has been validated in other clinical populations
Patient Recruitment at time of randomization (postpartum day 1) The investigators will examine the total number of subjects that were approached and the reasons for ineligibility and non-participation.
Patient Retention At postpartum visit (6 weeks after delivery) The investigators will record reasons for failure to complete in hospital diabetes screening and treatment.
Trial Locations
- Locations (1)
University of Massachusetts Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States