Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06457139

Preventing T2DM After GDM 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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, 01605, United States

Location status: Recruiting

Location contact

Gianna L Wilkie, MD

CONTACT

[email protected]

508-334-4067

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glucose tolerance test (2 hour)

Diagnostic Test

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

Active comparator

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.

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Gianna Wilkie, MD

CONTACT

[email protected]

508-3444982

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 13, 2024
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.