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NCT06401629Not yet recruiting

Outcomes After Unified Versus Standard GDM Diagnosis

The UPDATE-GDM Study: OUtcomes After NPRP anD ConventionAl CriTEria for GDM Diagnosis: A Pragmatic Randomised Trial

Source: ClinicalTrials.gov · Last updated 8 May 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
2650 (estimated)
First submitted
1 May 2024
Start date
1 Jan 2025
Primary completion date
1 Jun 2026
Lead sponsor
Qatar University
Diseases
Obesity
NCT number
NCT06401629

What you commit to

  • Study type: Interventional
  • Planned participants: 2650
  • From 1 Jan 2025 to the primary completion date, 1 Jun 2026
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • a multiple pregnancy at the time of screening, pre-existing diabetes (T1DM, T2DM)
  • known history of major conditions that could interfere with the study or pregnancy outcomes (e.g., severe liver, renal or cardiovascular disorders, chronic infections).

Lab values

  • any medical condition affecting glucose metabolism or the results of the GTT (e.g., Cushing's syndrome, bariatric surgery history)

Who the study is looking for

  • This will include broad eligibility criteria of age 18-45 years with or without risk factors at first antenatal care (ANC) visit who are willing to undergo testing at 24-28 weeks and able to provide informed consent.

Age in the registry: 18 years to 45 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.