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Early Detection of Gestational Diabetes Mellitus in Pregnancy

ConditionsGestational Diabetes Mellitus in PregnancyPregnancy, High Risk
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Massachusetts, Worcester

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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,

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Enhanced First Trimester GDM ScreeningExperimental treatment 1 intervention
Group B: Standard of Care GDM ScreeningActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Gestational Diabetes Mellitus

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

Time frame
In pregnancy (24-28 weeks gestation)

Secondary outcomes

1

Mode of Delivery

Mode of delivery (Vaginal versus Cesarean delivery)

Time frame
At Birth
2

Neonatal Birthweight

Neonatal Birthweight

Time frame
At Birth
3

Number of Participants with Shoulder Dystocia

Number of Participants with Shoulder Dystocia

Time frame
At Birth
4

Number of participants with brachial plexus injury

Number of participants with brachial plexus injury

Time frame
At Birth

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Massachusetts, Worcester

Lead sponsor

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

Collaborator

Source ClinicalTrials.gov
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