Preventing T2DM After GDM With Immediate Postpartum Screening

July 15, 2025 updated by: Gianna Wilkie, University of Massachusetts, Worcester

Preventing Type 2 Diabetes Mellitus After Gestational Diabetes Mellitus With Immediate Postpartum Screening

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Enrollment (Estimated)

116

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Worcester, Massachusetts, United States, 01605
        • Recruiting
        • University of Massachusetts Memorial Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Diagnostic test: Glucose tolerance test (2 hour)
Early testing with the 2 hour glucose tolerance test will occur during their inpatient postpartum hospitalization.
Active Comparator: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of Type 2 Diabetes Mellitus
Time Frame: At time of postpartum screening (postpartum day 1 or 6 week postpartum visit pending randomization arm)
Detection of Type 2 Diabetes Mellitus by 2 hour oral glucose tolerance test
At time of postpartum screening (postpartum day 1 or 6 week postpartum visit pending randomization arm)
Glycemic Outcomes--Hemoglobin A1c
Time Frame: at time of postpartum screening (postpartum day 1 or 6 week postpartum visit pending randomization arm)
Serum blood measurement of hemoglobin A1c
at time of postpartum screening (postpartum day 1 or 6 week postpartum visit pending randomization arm)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Satisfaction
Time Frame: At postpartum visit (6 weeks after delivery)
Participant satisfaction will be assessed using the validated survey, the Patient Satisfaction Survey. The survey was developed in 1979 and has been used to assess patient satisfaction with research participation based on 8 simple questions. It has not been used in a randomized trial in an obstetric population but has been validated in other clinical populations
At postpartum visit (6 weeks after delivery)
Patient Recruitment
Time Frame: at time of randomization (postpartum day 1)
The investigators will examine the total number of subjects that were approached and the reasons for ineligibility and non-participation.
at time of randomization (postpartum day 1)
Patient Retention
Time Frame: At postpartum visit (6 weeks after delivery)
The investigators will record reasons for failure to complete in hospital diabetes screening and treatment.
At postpartum visit (6 weeks after delivery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Massachusetts, Worcester

Investigators

  • Principal Investigator: Gianna Wilkie, MD, UMASS Memorial Healthcare

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2025

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

June 6, 2024

First Submitted That Met QC Criteria

June 12, 2024

First Posted (Actual)

June 13, 2024

Study Record Updates

Last Update Posted (Actual)

July 18, 2025

Last Update Submitted That Met QC Criteria

July 15, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00001870

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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