Preventing T2DM After GDM With Immediate Postpartum Screening

NCT06457139 | Recruiting DMC

• 1 other identifier: STUDY00001870
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes; Type 2 Diabetes

Keywords

diabetes

Outcome Measures

Primary Outcomes (2)

• Detection of Type 2 Diabetes Mellitus

  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

  Serum blood measurement of hemoglobin A1c

  at time of postpartum screening (postpartum day 1 or 6 week postpartum visit pending randomization arm)

Secondary Outcomes (3)

• Patient Satisfaction

  At postpartum visit (6 weeks after delivery)

• Patient Recruitment

  at time of randomization (postpartum day 1)

• Patient Retention

  At postpartum visit (6 weeks after delivery)

Study Arms (2)

Early Postpartum GDM Screening

EXPERIMENTAL

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)

Standard of Care Postpartum Screening

ACTIVE COMPARATOR

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

Interventions

Glucose tolerance test (2 hour) DIAGNOSTIC_TEST

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

Early Postpartum GDM Screening

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.

Standard of Care Postpartum Screening

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead

Study Sites (1)

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, 01605, United States

RECRUITING

Related Publications (5)

• Werner EF, Has P, Rouse D, Clark MA. Two-day postpartum compared with 4- to 12-week postpartum glucose tolerance testing for women with gestational diabetes. Am J Obstet Gynecol. 2020 Sep;223(3):439.e1-439.e7. doi: 10.1016/j.ajog.2020.05.036. Epub 2020 May 26.

  PMID: 32470456 BACKGROUND

• Waters TP, Kim SY, Werner E, Dinglas C, Carter EB, Patel R, Sharma AJ, Catalano P. Should women with gestational diabetes be screened at delivery hospitalization for type 2 diabetes? Am J Obstet Gynecol. 2020 Jan;222(1):73.e1-73.e11. doi: 10.1016/j.ajog.2019.07.035. Epub 2019 Jul 24.

  PMID: 31351065 BACKGROUND

• Dinglas C, Muscat J, Heo H, Islam S, Vintzileos A. Immediate Postpartum Glucose Tolerance Testing in Women with Gestational Diabetes: A Pilot Study. Am J Perinatol. 2017 Oct;34(12):1264-1270. doi: 10.1055/s-0037-1606620. Epub 2017 Sep 14. No abstract available.

  PMID: 28910846 BACKGROUND

• Ratner RE, Christophi CA, Metzger BE, Dabelea D, Bennett PH, Pi-Sunyer X, Fowler S, Kahn SE; Diabetes Prevention Program Research Group. Prevention of diabetes in women with a history of gestational diabetes: effects of metformin and lifestyle interventions. J Clin Endocrinol Metab. 2008 Dec;93(12):4774-9. doi: 10.1210/jc.2008-0772. Epub 2008 Sep 30.

  PMID: 18826999 BACKGROUND

• Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512.

  PMID: 11832527 BACKGROUND

MeSH Terms

Conditions

Diabetes, Gestational; Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Glucose Tolerance Test

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Investigative Techniques

Study Officials

• Gianna Wilkie, MD

  UMASS Memorial Healthcare

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gianna Wilkie, MD

CONTACT

508-3444982; Gianna.Wilkie@umassmemorial.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: June 13, 2024
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)