RECRUITING

Early Detection of Gestational Diabetes Mellitus in Pregnancy

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Conditions

Gestational Diabetes Mellitus in PregnancyPregnancy, High RiskPregnancyGestational DiabetesScreeningMaternal OutcomesNeonatal Outcomes

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to develop an implementation protocol and test the feasibility and acceptability of a first trimester screening protocol for the early detection of gestational diabetes mellitus (GDM).

Official Title

Early Detection of Gestational Diabetes Mellitus in Pregnancy: A Randomized Trial

Quick Facts

Study Start:2025-08-18
Study Completion:2026-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05388643

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 1\) age greater than or equal to 18 years old,
  2. * 2\) singleton gestation less than or equal to 12 weeks at initial obstetric visit,
  3. * 3\) receiving prenatal care at UMMHC and plans to deliver at UMMHC,
  4. * 4\) able and willing to provide informed consent,
  5. * 5\) English or Spanish speaking, and
  6. * 6\) are at high risk for developing GDM by ACOG clinical risk factor guidelines.
  1. * 1\) known diagnosis of pre-existing pregestational diabetes,
  2. * 2\) plan to receive prenatal care or deliver outside of UMMHC,
  3. * 3\) inability to complete oral glucose tolerance test (e.g. gastric bypass surgery history, gastric dumping syndrome history, vomiting of oral glucose tolerance test), or
  4. * 4\) systemic steroid use.

Contacts and Locations

Study Contact

Gianna L Wilkie, MD
CONTACT
77743642523
Gianna.Wilkie@umassmemorial.org

Principal Investigator

Gianna Wilkie, MD
PRINCIPAL_INVESTIGATOR
University of Massachusetts Chan Medical School

Study Locations (Sites)

University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01605
United States

Collaborators and Investigators

Sponsor: University of Massachusetts, Worcester

  • Gianna Wilkie, MD, PRINCIPAL_INVESTIGATOR, University of Massachusetts Chan Medical School

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 Registration Dates

Study Start Date2025-08-18
Study Completion Date2026-12-01

Study Record Updates

Study Start Date2025-08-18
Study Completion Date2026-12-01

Terms related to this study

Keywords Provided by Researchers

  • Pregnancy
  • Gestational Diabetes
  • Screening
  • Maternal Outcomes
  • Neonatal Outcomes

Additional Relevant MeSH Terms

  • Gestational Diabetes Mellitus in Pregnancy
  • Pregnancy, High Risk