Gestational Diabetes Clinical Trial
Official title:
A Randomized Controlled Trial of Diabetes Screening Immediately Postpartum
NCT number | NCT05909046 |
Other study ID # | 2023H0189 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 24, 2023 |
Est. completion date | December 2024 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine | Columbus | Ohio |
Lead Sponsor | Collaborator |
---|---|
Ohio State University |
United States,
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 |
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