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

NCT05909046 | Recruiting

• 1 other identifier: 2023H0189
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Pre-Gestational Diabetes; Type2diabetes; Pregnancy in Diabetic; Pregnancy, High Risk; Gestational Diabetes; Gestational Diabetes Mellitus in the Puerperium

Keywords

2-hour oral glucose tolerance test (OGTT); Pregnancy; diabetes mellitus screening; postpartum; cardiometabolic health; cardiovascular health; type 2 diabetes; prediabetes

Outcome Measures

Primary Outcomes (3)

• Rate of postpartum diabetes mellitus screening

  For patients randomized to inpatient immediate postpartum OGTT, completion of the inpatient test will be confirmed and documented by study staff prior to patient discharge. For patients randomized to the inpatient immediate postpartum OGTT who do not undergo inpatient testing and for patients randomized to the outpatient 4-12 week OGTT, individuals will receive an electronic survey via email at 12 weeks inquiring as to whether they underwent postpartum outpatient OGTT and about the results of testing, if performed.

  From delivery to up to 12 weeks postpartum

• Patient reported outcome of postpartum Cardiovascular health (CVH) counseling received within the first 12 months after delivery

  Patient reported outcome of postpartum CVH counseling received within the first 12 months after delivery measured with modified questions from the Pregnancy Risk Assessment Monitoring System (PRAMS) Phase 9 Core Mail Questionnaire and the clinical outcome of postpartum dysglycemia defined as a diagnosis of prediabetes or type 2 diabetes within the first 12 months after delivery.

  Within the first 12 months after delivery

• Patient perspectives, preferences and barriers to engagement with respective to postpartum interventions to improve CVH.

  Semi-structured virtual interviews will be performed including questions that encompass patient perspectives, preferences and barriers to engagement with respective to postpartum interventions to improve CVH.

  Between 12 and 24 months postpartum

Secondary Outcomes (5)

• Risk perception and lifestyle modification

  From delivery to up to 12 weeks postpartum

• Rates of primary care provider (PCP) visits within 1 year of delivery

  Within 1 year postpartum

• Risk Perception Survey for Developing Diabetes

  From delivery to up to 12 weeks postpartum

• Diabetes Treatment Satisfaction Questionnaire

  From delivery to up to 12 weeks postpartum

• Prediabetes or type 2 diabetes

  Within 1 year postpartum

Study Arms (2)

Immediate inpatient postpartum OGTT

ACTIVE COMPARATOR

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

Diagnostic Test: Immediate inpatient postpartum OGTT

Standard of care

OTHER

Standard of care is 4-12 week outpatient postpartum OGTT

Diagnostic Test: Standard of care 4-12 week postpartum OGTT

Interventions

Immediate inpatient postpartum OGTT DIAGNOSTIC_TEST

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

Immediate inpatient postpartum OGTT

Standard of care 4-12 week postpartum OGTT DIAGNOSTIC_TEST

Standard of care is 4-12 week outpatient postpartum OGTT

Standard of care

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: This study is restricted to pregnant individuals.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

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

Columbus, Ohio, 43210, United States

RECRUITING

MeSH Terms

Conditions

Pregnancy in Diabetics; Diabetes, Gestational; Diabetes Mellitus, Type 2; Prediabetic State

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Christine Field, MD, MPH

  Ohio State University

  PRINCIPAL INVESTIGATOR

• Kartik K Venkatesh, MD, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kartik Venkatesh, MD, PhD

CONTACT

614-293-2222; kartik.venkatesh@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 9, 2023
• First Posted: June 18, 2023
• Study Start: July 24, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)