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NCT06457139 | NOT YET RECRUITING | Gestational Diabetes

Preventing T2DM After GDM With Immediate Postpartum Screening
Sponsor:

University of Massachusetts, Worcester

Information provided by (Responsible Party):

Gianna Wilkie

Brief Summary:

The overall goal of this proposal is to create and test an implementation protocol for in-hospital immediate postpartum diabetes screening for postpartum patients with pregnancies affected by GDM.

Condition or disease

Gestational Diabetes

Type 2 Diabetes

Intervention/treatment

Glucose tolerance test (2 hour)

Active Comparator

Phase

NA

Detailed Description:

Gestational diabetes mellitus (GDM) affects 6 to 8% of U.S. pregnancies annually and upwards of 1 in every 8 pregnancies worldwide. Pregnant individuals with GDM have higher rates of hypertensive disorders of pregnancy, cesarean delivery, and maternal mortality as compared to those without GDM. While GDM frequently resolves after delivery, up to 70% of patients will develop type 2 diabetes mellitus (T2DM) later in life10 and one third will develop subsequent diabetes or impaired glucose metabolism at the time of postpartum screening. While postpartum screening is recommended by the American College of Obstetricians and Gynecologists (ACOG) and the American Diabetes Association (ADA) between 4-12 weeks postpartum for all patients with GDM in pregnancy, nearly 40% of patients do not attend a postpartum visit. Attendance is even lower among populations with limited resources, contributing to health disparities. To address this issue, immediate in-hospital postpartum glucose tolerance testing has been evaluated and found to yield diagnostic values comparable to postpartum screening with the advantage of \~100% adherence. However, 2 challenges remain: currently there is a lack of widespread clinical implementation of in-hospital immediate postpartum diabetes screening. Therefore, the overall goal of this proposal is to randomize patients to early screening during their postpartum hospitalization versus at their 6 week postpartum visit (current standard of care).

Study Type : INTERVENTIONAL
Estimated Enrollment : 116 participants
Masking : SINGLE
Primary Purpose : SCREENING
Official Title : Preventing Type 2 Diabetes Mellitus After Gestational Diabetes Mellitus With Immediate Postpartum Screening
Actual Study Start Date : 2025-06-01
Estimated Primary Completion Date : 2028-06-01
Estimated Study Completion Date : 2028-12-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * pregnancy complicated by GDM as diagnosed with traditional two step testing in the third trimester according to Carpenter-Coustan Criteria
  • * receiving prenatal care at UMASS Memorial and plans to deliver at UMASS Memorial
  • * able and willing to provide informed consent
  • * ability to complete immediate in hospital postpartum glucose testing
  • * have evidence of impaired glucose metabolism defined as fasting glucose value of ≥126 mg/dL or 2-hour glucose value of ≥200 mg/dL
Exclusion Criteria
  • * known diagnosis of pre-existing pre-gestational diabetes in pregnancy
  • * inability to complete oral glucose tolerance test (e.g. gastric bypass surgery history, gastric dumping syndrome history, vomiting of oral glucose tolerance test) in pregnancy or immediately postpartum
  • * systemic steroid use
Preventing T2DM After GDM With Immediate Postpartum Screening

Location Details

NCT06457139

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How to Participate

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Locations

Not yet recruiting

United States, Massachusetts

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, United States, 01605