What this study is
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
What's being tested
- Immediate inpatient postpartum OGTT
Intervention · DIAGNOSTIC TEST
The intervention includes immediate inpatient postpartum 2-hour oral glucose tolerance test (OGTT) prior to delivery discharge
- Standard of care 4-12 week postpartum OGTT
Intervention · DIAGNOSTIC TEST
Standard of care is 4-12 week outpatient postpartum OGTT
Study details
- Official title
- 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
- Conditions
- Pre-Gestational Diabetes · Type2diabetes · Pregnancy in Diabetic · Pregnancy, High Risk · Gestational Diabetes · Gestational Diabetes Mellitus in the Puerperium
- Enrolling
- 104 people
- Starts
- 2023-07-24
- Est. completion
- 2026-12
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex FEMALEHealthy volunteers Not acceptedAll participants
You may qualify if
- DIP - 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
You can't join if
- 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
You may qualify if
- Enrolled DIP participants who are English speaking will be eligible for PP CARE follow up if they are between 12 and 24 months postpartum.
You can't join if
- Spanish speaking DIP participants will be excluded because the study team does not include anyone who is Spanish speaking.
- Individuals who cannot tolerate a 2-hour oral glucose tolerance test (OGTT) (i.e. history of gastric bypass)
- Not English or Spanish speaking
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openThe Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
Columbus, Ohio, United States
- Kartik Venkatesh, MD, PhD · Contact614-293-2222Kartik.Venkatesh@osumc.edu
Recruiting
Study team
Sponsor
Ohio State University
Study ID 2023H0189
Principal investigator
Christine Field, MD, MPH
Ohio State University
Principal investigator
Kartik K Venkatesh, MD, PhD
Ohio State University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.