A Randomized Controlled Trial of Diabetes Screening Immediately Postpartum (DIP) and Follow Up PP CARE

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorOhio State University

About this trial

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

Eligibility criteria

Qualifiers

Immediately postpartum individuals during their delivery hospital admission

≥ 18 years old with the ability to give informed consent.

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

Disqualifiers

Individuals who cannot tolerate a 2-hour oral glucose tolerance test (OGTT) (i.e. history of gastric bypass)

Not English or Spanish speaking

Trial design

Treatments tested in this trial

  • Immediate inpatient postpartum OGTT
  • Standard of care 4-12 week postpartum OGTT

Treatment groups

104 Participants
are divided into 2 treatment groups

Sponsors and collaborators