Clinical trial NCT05909046: A Randomized Controlled Trial of Diabetes Screening Immediately Postpartum (DIP)
Official title: A Randomized Controlled Trial of Diabetes Screening Immediately Postpartum
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
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
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 104
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of postpartum diabetes mellitus screening
timeFrame: From delivery to up to 12 weeks postpartum
Secondary outcomes:
measure: Risk perception and lifestyle modification
timeFrame: From delivery to up to 12 weeks postpartum
measure: Rates of primary care provider (PCP) visits within 1 year of delivery
timeFrame: Within 1 year postpartum
measure: Risk Perception Survey for Developing Diabetes
timeFrame: From delivery to up to 12 weeks postpartum
measure: Diabetes Treatment Satisfaction Questionnaire
timeFrame: From delivery to up to 12 weeks postpartum
measure: Prediabetes or type 2 diabetes
timeFrame: Within 1 year postpartum
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
state: Ohio
Study officials:
affiliation: Ohio State University
name: Christine Field, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ohio State University
name: Kartik K Venkatesh, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: