RecruitingNot ApplicableNCT05909046

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

A Randomized Controlled Trial of Diabetes Screening Immediately Postpartum (DIP) - Follow up Study: Patient Perspectives on Postpartum Interventions to Improve Future Maternal CARdiovascular hEalth After Gestational Diabetes (PP CARE)


Sponsor

Ohio State University

Enrollment

104 participants

Start Date

Jul 24, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria7

  • 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

Exclusion Criteria2

  • Individuals who cannot tolerate a 2-hour oral glucose tolerance test (OGTT) (i.e. history of gastric bypass)
  • Not English or Spanish speaking

Interventions

DIAGNOSTIC_TESTImmediate inpatient postpartum OGTT

The intervention includes immediate inpatient postpartum 2-hour oral glucose tolerance test (OGTT) prior to delivery discharge

DIAGNOSTIC_TESTStandard of care 4-12 week postpartum OGTT

Standard of care is 4-12 week outpatient postpartum OGTT


Locations(1)

The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine

Columbus, Ohio, United States

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NCT05909046


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