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NCT Number: NCT05388643

Early Detection of Gestational Diabetes Mellitus in Pregnancy

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).

Recruiting

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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) is an important contributor to both maternal and neonatal morbidity and mortality in pregnancy. GDM has lifelong complications including an increased risk of developing type 2 diabetes mellitus and cardiovascular disease for women, and their offspring are at higher risk of being obese and also having diabetes in childhood and adolescence. Approximately 1 in 8 pregnancies is impacted by gestational diabetes mellitus worldwide. First trimester GDM screening is varied due to conflicting national guidelines, and the best strategy is unknown. The goal of the proposed research is to develop an implementation protocol and test the feasibility and acceptability of a first trimester screening protocol for the early detection of GDM. The investigators will utilize a pilot randomized controlled trial to recruit 80 high-risk pregnant women in the first trimester, of whom half will receive protocolized early GDM screening with serum biomarkers before 12 weeks and the remaining half will receive the current standard of care with screening between 24 and 28 weeks of gestation with possible early screening based on provider discretion.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 1) age greater than or equal to 18 years old,
  • 2) singleton gestation less than or equal to 12 weeks at initial obstetric visit,
  • 3) receiving prenatal care at UMMHC and plans to deliver at UMMHC,
  • 4) able and willing to provide informed consent,
  • 5) English or Spanish speaking, and
  • 6) are at high risk for developing GDM by ACOG clinical risk factor guidelines.

Exclusion criteria

  • 1) known diagnosis of pre-existing pregestational diabetes,
  • 2) plan to receive prenatal care or deliver outside of UMMHC,
  • 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) systemic steroid use.

Treatment and study plan

Enhanced First Trimester GDM Screening

Diagnostic Test

Women who are randomly assigned to this condition will be required to have early glucose screening with a prediction model composed of additional clinical risk factors and serum biomarkers (triglycerides, PAPP-A, and lipocalin-2) with their initial prenatal laboratory assessment.

Routine Gestational Diabetes Screening

Diagnostic Test

Women who will be randomized to the comparison condition of usual standard of care will undergo routine standard of care. The standard of care will consist of routine screening for diabetes in pregnancy between 24 to 28 weeks of gestation via the two-step screening method with possible early screening with either plasma fasting glucose, oral glucose tolerance test, or hemoglobin A1c at the providers discretion to represent true clinical practice.

Other names: Third Trimester Screening

Primary outcomes

  1. Gestational Diabetes Mellitus

    Time frame: In pregnancy (24-28 weeks gestation)

    Confirmed diagnosis of GDM based on 3 hour 100 gram glucose tolerance test

Secondary outcomes

  1. Mode of Delivery

    Time frame: At Birth

    Mode of delivery (Vaginal versus Cesarean delivery)

  2. Neonatal Birthweight

    Time frame: At Birth

    Neonatal Birthweight

  3. Number of Participants with Shoulder Dystocia

    Time frame: At Birth

    Number of Participants with Shoulder Dystocia

  4. Number of participants with brachial plexus injury

    Time frame: At Birth

    Number of participants with brachial plexus injury

  5. APGAR Score

    Time frame: At Birth

    APGAR Score (range 0 to 10, with 10 being the best)

  6. Neonatal Intensive Care Unit Admission

    Time frame: At delivery and within first 2 days of life

    Admission to Level 2 or greater neonatal ICU and length of stay

  7. Gestational Age at Delivery

    Time frame: At Birth

    Gestational Age at Delivery

  8. Patient Satisfaction with Diabetes Screening Method

    Time frame: Postpartum day 1 after birth

    This will be assessed by the Patient Satisfaction Survey questionnaire, which is scored out of 30, with 30 being the highest score)

Study contacts

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

Gianna L Wilkie, MD

CONTACT

[email protected]

77743642523

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 24, 2022
Registry last updated
Apr 6, 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.

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