Preventing T2DM After GDM With Immediate Postpartum Screening

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2028-12-01

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Gestational Diabetes Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Early Postpartum GDM Screening

Subjects who are randomly assigned to this condition will be screened for GDM with the recommended 2-hour glucose tolerance test during their postpartum hospitalization.

Group Type EXPERIMENTAL

Glucose tolerance test (2 hour)

Intervention Type DIAGNOSTIC_TEST

Early testing with the 2 hour glucose tolerance test will occur during their inpatient postpartum hospitalization.

Standard of Care Postpartum Screening

Subjects randomized to the comparison condition will receive the usual standard of care. The standard of care will consist of screening with a 2 hour glucose tolerance test at 6-12 weeks postpartum.

Group Type ACTIVE_COMPARATOR

Active Comparator

Intervention Type OTHER

Subjects randomized to the comparison condition will receive the usual standard of care. The standard of care will consist of administration of educational materials adapted from the American Diabetes Association that discusses healthy lifestyle behaviors and the increased risks of developing T2DM after a pregnancy complicated by GDM.

Interventions

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Glucose tolerance test (2 hour)

Early testing with the 2 hour glucose tolerance test will occur during their inpatient postpartum hospitalization.

Intervention Type DIAGNOSTIC_TEST

Active Comparator

Subjects randomized to the comparison condition will receive the usual standard of care. The standard of care will consist of administration of educational materials adapted from the American Diabetes Association that discusses healthy lifestyle behaviors and the increased risks of developing T2DM after a pregnancy complicated by GDM.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No