A Randomized Controlled Trial of Diabetes Screening Immediately Postpartum (DIP) and Follow Up PP CARE
Recruiting · NCT05909046 · Interventional (participants receive a specific treatment) · Lead sponsor: Ohio State University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
DIP : To conduct a pragmatic, non-blinded randomized controlled trial (pRCT) of immediate in-patient postpartum OGTT prior to delivery discharge (intervention) versus 4-12 week outpatient postpartum OGTT (current standard care) to improve the frequency of post-partum diabetes screening among individuals with a pregnancy complicated by GDM. Follow up PP CARE: To engage with individuals with a history of GDM through a patient-centered mixed-methods survey and qualitative assessment to evaluate the barriers to and facilitators of Cardiovascular health (CVH) counseling and risk-reduction postpartum at the patient and healthcare system levels inclusive of Social determinants of health (SDOH) and structural factors, as well as patient preferences and perspectives on CVH and wellness interventions
Who can take part
Inclusion criteria
- Immediately postpartum individuals during their delivery hospital admission
- ≥ 18 years old with the ability to give informed consent.
- Diagnosed with GDM during pregnancy by:
- Elevated one-hour 50-gram glucose challenge test any time during pregnancy AND provider documentation of gestational diabetes (NOT pregestational diabetes) diagnosis OR
- Two elevated values on a 3-hour 100-gram glucose tolerance test any time in pregnancy AND provider documentation of gestational diabetes (NOT pregestational diabetes) diagnosis
- English or Spanish speaking
- Receiving prenatal and postpartum care at OSU
- DIP-
Exclusion criteria
- Individuals who cannot tolerate a 2-hour oral glucose tolerance test (OGTT) (i.e. history of gastric bypass)
- Not English or Spanish speaking
- PP CARE Inclusion criteria: Enrolled DIP participants who are English speaking will be eligible for PP CARE follow up if they are between 12 and 24 months postpartum.
- PP CARE Exclusion criteria: Spanish speaking DIP participants will be excluded because the study team does not include anyone who is Spanish speaking.
Where it is running
1 location listed across 1 US state.
- The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine - Columbus, Ohio, United States