A Randomized Controlled Trial of Diabetes Screening Immediately Postpartum (DIP)

Gestational Diabetes Clinical Trial

Official title:

A Randomized Controlled Trial of Diabetes Screening Immediately Postpartum

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05909046
• Other study ID #: 2023H0189
• Status: Recruiting
• Phase: N/A
• Start date: July 24, 2023
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Ohio State University
• Contact: Kartik Venkatesh, MD, PhD
• Phone: 614-293-2222
• Email: kartik.venkatesh[@]osumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Individuals with gestational diabetes (GDM) during pregnancy have up to a 10-fold increased risk of developing of T2DM. Postpartum screening facilitates detection of impaired glucose tolerance and diabetes mellitus with the possibility for subsequent preventive and treatment interventions. The American College of Obstetricians and Gynecologists (ACOG) and the American Diabetes Association (ADA) recommend screening individuals with GDM postpartum with a 75-g, 2-hour oral glucose tolerance test (OGTT) that includes a fasting blood glu-cose.4,6 This is historically performed at 4-12 weeks so that it will coincide with the timing of the typical postpartum visit. However, the rate of postpartum screening with the recommended method are low, as many individuals do not seek timely postpartum care-only a quarter to one half of individuals undergo diabetes screening in the first year postpartum. Multiple structural barriers exist for patients and healthcare providers to effectively complete postpartum diabetes screening via the current recommended method. An immediate postpartum OGTT has been proposed as an alternative to the current standard practice which is generally performed between 4-12 week postpartum OGTT at the routine postpartum visit. An immediate OGTT has comparable performance characteristics for detection of impaired glucose tolerance and diabetes compared with a 4-12 week postpartum OGTT.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: December 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes
• Pre-Gestational Diabetes
• Pregnancy in Diabetic
• Pregnancy in Diabetics
• Pregnancy, High Risk

Intervention

Diagnostic Test:
• Immediate inpatient postpartum OGTT
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
Standard of care is 4-12 week outpatient postpartum OGTT

Locations

Country	Name	City	State
United States	The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Risk perception and lifestyle modification	"What do you think your risk or chance is for getting diabetes over the next 10 years?" (Responses: "almost no chance," "a slight chance," "a moderate chance," or "a high chance."); "If you don't change your lifestyle behaviors, such as diet or exercise, what is your risk or chance of getting diabetes over the next 10 years?" (Responses: "almost no chance," "a slight chance," "a moderate chance," or "a high chance."); "Have you recently made changes in any lifestyle behaviors that you believe will lower your chance of getting diabetes?" (Responses: yes, no); "Are you planning to make changes in any lifestyle behaviors in the near future that you believe will lower your chances of getting diabetes?" (Responses: yes, no)	From delivery to up to 12 weeks postpartum
Secondary	Rates of primary care provider (PCP) visits within 1 year of delivery	All individuals will be sent an electronic survey via email inquiring as to whether they have attended a visit with a primary care provider (internal medicine, family medicine or primary care nurse practitioner) and for what reason since the time of their delivery.	Within 1 year postpartum
Secondary	Risk Perception Survey for Developing Diabetes	The survey comprises 53 items and has four subscales and other individual items to address various dimensions of risk perception. Risk perception will be assessed as both continuous scales and as a dichotomous outcome ("no chance" and "slight chance" will be categorized as "low" risk perception, and "moderate chance" and "high chance" will be categorized as "high" risk perception.	From delivery to up to 12 weeks postpartum
Secondary	Diabetes Treatment Satisfaction Questionnaire	8 question survey will be scored as a continuous scale.	From delivery to up to 12 weeks postpartum
Secondary	Prediabetes or type 2 diabetes	Prediabetes: OGTT between 140 to 199 mg/dl AND/OR A1c 5.7% to 6.4% AND/OR patient self-report Type 2 diabetes: OGTT 200 mg/dl or higher AND/OR A1c 6.5% or higher AND/OR patient self-report	Within 1 year postpartum