Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06401629
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-05-01
Brief Title:
Outcomes After Unified Versus Standard GDM Diagnosis
Sponsor:
Qatar University
Organization:
Qatar University
Study Overview
Official Title:
The UPDATE-GDM Study OUtcomes After NPRP anD ConventionAl CriTEria for GDM Diagnosis A Pragmatic Randomised Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
UPDATE-GDM
Brief Summary:
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
Detailed Description:
This research project explores a crucial aspect of maternal and fetal health the diagnosis of gestational diabetes mellitus GDM a condition that poses risks to both pregnant women and the babies Gestational diabetes is a condition that can develop during pregnancy characterized by dysglycemia and associated risks of complications such as pre-eclampsia cesarean delivery and macrosomia For the baby it raises the risk of developing obesity type 2 diabetes later in life and metabolic syndrome Therefore early and accurate diagnosis is paramount to manage and mitigate these risks The IADPSG International Association of Diabetes and Pregnancy Study Groups criteria the current standard for GDM diagnosis has been widely adopted due to its putative sensitivity in detecting GDM and potential for reducing GDM-related complications However this method is not without its limitations including the risk of over- or under-diagnosis of GDM This project will investigate the efficacy of an alternative diagnostic method the National Priorities Research Program NPRP criteria against the conventional IADPSG criteria diagnosis usually being undertaken between the 24th and 28th weeks of pregnancy The NPRP criteria are based on a unified assessment of the oral glucose tolerance test GTT which could offer a four-level classification of dysglycemia in pregnancy as opposed to the binary diagnosis by the IADPSG criteria thus having the added benefit of glycemic risk stratification during pregnancy By comparing the outcomes of pregnancies diagnosed using the NPRP criteria against those diagnosed using the IADPSG criteria the investigators aim to assess whether the NPRP criteria can provide improved outcomes Bashir et al 2021 in terms of maternal and fetal health through better informed GDM-related decision-making In addition this study proposes the NPRP criteria as potentially able to mitigate over- and under-diagnosis of GDM This study will employ a parallel-group prospective randomized pragmatic controlled trial design and the study investigators will work closely with a cohort of pregnant women throughout pregnancy employing both diagnostic methods to evaluate their impact on the health of the mother and the baby The evaluation will not only focus on the immediate outcomes during pregnancy but will also aim to follow up on longer-term metabolic health implications for both mother and child post-delivery after the trial is completed and if the participant consents to such additional follow-up The significance of this research lies in its potential to transform the current practices in GDM diagnosis by offering evidence on the effectiveness and benefits of the NPRP criteria thus paving the way for a shift towards a more patient-centered approach to the diagnosis of gestational diabetes Determining if the NPRP criteria can lead to better health outcomes for mothers and babies can have profound implications for maternal and child health Improved diagnostic methods could lead to more timely interventions reducing the prevalence of complications associated with gestational diabetes and improving the quality of life for countless families Through this study the investigators hope to make a significant contribution to the well-being of pregnant women and babies ensuring a healthier start for the next generation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None