Outcomes After Unified Versus Standard GDM Diagnosis

Sponsor
Qatar University
Study ID
NCT06401629
Status
Not Yet Recruiting

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Conditions

  • Diagnosis
  • Gestational Diabetes
  • Pregnancy

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • NPRP criteria — DIAGNOSTIC_TEST
    Under the NPRP criterion, the plasma glucose level at each time point (TP1, TP2, and TP3) is multiplied by its weight (Doi et al. 2022), and the sum of these products yields the unified Doi's Weighted Average Glucose (dwAG) value for each woman. The dwAG is then categorized into four groups: a dwAG of 6.8 or lower, \>6.8 to ≤7.5, \>7.5 to ≤8.6, and above 8.6 mmol/L, indicating normal gestational glycemia (NGG), impaired gestational glycemia (IGG), gestational diabetes mellitus (GDM), and high-risk gestational diabetes mellitus (hGDM), respectively (Doi et al. 2022).
  • IADPSG criteria — DIAGNOSTIC_TEST
    The IADPSG criteria define GDM as any one of the three-time points above specific thresholds: the time point prior to glucose ingestion (TP1) is considered abnormal when the fasting plasma glucose (FPG) value is ≥ 5.1 mmol/L, the 1-hour time-point after glucose ingestion (TP2) is considered abnormal when the value is ≥ 10 mmol/L, and the 2-hour time-point after glucose ingestion (TP3) is considered abnormal when the Post-Load Plasma Glucose levels are ≥ 8.5 mmol/L (Metzger et al. 2010). Put simply, meeting any one of these cut-offs results in a GDM diagnosis, regardless of whether the other time points show normal values or not (Metzger et al. 2010).

Study Details

Gestational diabetes mellitus (GDM) is a condition that can affect pregnant women during pregnancy and may cause complications for the mother and the baby. Therefore, early and accurate detection is necessary to provide the woman and the baby with better health outcomes. Currently, the most commonly used criteria to detect GDM is the International Association of Diabetes and Pregnancy Study Groups (IADPSG) criterion. However, there is a suggestion that it results in over-diagnosis of GDM, and newer methods of diagnosis have been proposed. One such proposal is to have more than a binary outcome of assessment of dysglycemia in pregnancy. The investigator group created this criterion known as the National Priorities Research Program (NPRP) criterion. This clinical trial compares the IADPSG to the NPRP criteria in pregnant women in Qatar to determine if this newer method mitigates overdiagnosis and more accurately identifies women at risk of complications.

Key Dates

First listed
May 7, 2024
Start date
Jan 1, 2025
Status verified
May 2024
Primary completion
Jun 1, 2026
Completion
Jun 1, 2027

Study Design

Enrollment
2,650 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: National Priorities Research Program (NPRP) diagnostic criterion
    Interventional diagnostic strategy
  • Active Comparator: International Association of Diabetes and Pregnancy Study Groups (IADPSG) diagnostic criterion
    Control diagnostic strategy

Primary Outcome Measure

large for gestational age (LGA) [ Time Frame: Through pregnancy completion, an average of 9 months ]

Central Contacts

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