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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)

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Ohio
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
RECRUITING
Columbus
Contact Information
Primary
Kartik Venkatesh, MD, PhD
kartik.venkatesh@osumc.edu
614-293-2222
Time Frame
Start Date: 2023-07-24
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 104
Treatments
Active_comparator: Immediate inpatient postpartum OGTT
The intervention includes immediate inpatient postpartum 2-hour oral glucose tolerance test (OGTT) prior to delivery discharge
Other: Standard of care
Standard of care is 4-12 week outpatient postpartum OGTT
Related Therapeutic Areas
Sponsors
Leads: Ohio State University

This content was sourced from clinicaltrials.gov