Outcomes After Unified Versus Standard GDM Diagnosis (UPDATE-GDM)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pregnancy; Gestational Diabetes; Diagnosis
• Intervention / Treatment: Diagnostic test: IADPSG criteria; Diagnostic test: NPRP criteria

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 Type: Interventional
• Enrollment (Estimated): 2650
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Suhail A. Doi, MBBS, PhD; Phone Number: +974 66001271; Email: sdoi@qu.edu.qa
• Study Contact Backup: Name: Mohammed Bashir, MD; Email: mbashir@hamad.qa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• a multiple pregnancy at the time of screening, pre-existing diabetes (T1DM, T2DM)
• any medical condition affecting glucose metabolism or the results of the GTT (e.g., Cushing's syndrome, bariatric surgery history)
• known history of major conditions that could interfere with the study or pregnancy outcomes (e.g., severe liver, renal or cardiovascular disorders, chronic infections).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: National Priorities Research Program (NPRP) diagnostic criterion; Interventional diagnostic strategy	Diagnostic test: NPRP criteria; 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).
Active Comparator: International Association of Diabetes and Pregnancy Study Groups (IADPSG) diagnostic criterion; Control diagnostic strategy	Diagnostic test: IADPSG criteria; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
large for gestational age (LGA)	infants who weigh > 90th percentile for gestational age	Through pregnancy completion, an average of 9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemic targets unmet	Reports: Number with any of the following: Need to move to insulin; readmission for poor glycemic control; intervention targets unmet	Through pregnancy completion, an average of 9 months
Adverse events related to treatment	Report: Number (by group) reporting any GI or systemic adverse effects and split by: Maternal hypoglycemia (glucose < 4 mmol/L or who received inter-venous glucose rescue); Others (excluding hypoglycemia)	Through pregnancy completion, an average of 9 months
Hypoglycemia within 1 hour of birth	Report: Number (by group) with hypoglycemia (<=1.65 mmol/L)	Through pregnancy completion, an average of 9 months
Assisted labor/delivery (including cesarean)	Report: Number (by group) of all assisted deliveries as well as split by: Non-cesarean: any of induction/augmentation/vacuum extraction/operative vaginal delivery etc.; Elective/Emergency Cesarean Section; Primary/repeated Cesarean Section	Through pregnancy completion, an average of 9 months
Preterm delivery	Report: Number (by group) with delivery at <37 weeks of gestation	Through pregnancy completion, an average of 9 months
Average plasma glucose	Report: Group mean and standard deviation (SD); for both pre-prandial and 2 hour postprandial glucose	Through pregnancy completion, an average of 9 months
Total weight gain in pregnancy (kg)	Report: Group means and SD of total weight gained during pregnancy	Through pregnancy completion, an average of 9 months
Birth weight (newborn's weight at birth)	Report: Numbers (by group) with LGA as well as group means and SD of continuous birth weight	Through pregnancy completion, an average of 9 months
Neonatal composite morbidity and mortality outcome	Report: number (by group) of any neonatal death, stillbirth, or neonatal intensive care unit (NICU) admission and also split by: NICU admission > 24 hours; Neonatal death (within 28 days of birth); Stillbirth	Through pregnancy completion, an average of 9 months
Peripartum infection	Report: Number (by group) of any of chorioamnionitis, urinary tract infections (UTI) or any other maternal infections	Through pregnancy completion, an average of 9 months
Pregnancy induced hypertension (PIH) or pre-eclampsia/ eclampsia	Report: Number (by group) of all PIH as well as split by; Eclampsia/pre-eclampsia; Other PIH	Through pregnancy completion, an average of 9 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Additional composite outcome	A composite of PIH, preterm delivery, LGA, NICU admission for >24h, and stillbirth after 24 weeks)	Through pregnancy completion, an average of 9 months

Collaborators and Investigators

• Sponsor: Qatar University
• Collaborators: Hamad Medical Corporation
• Investigators: Principal Investigator: Suhail A. Doi, MBBS, PhD, Qatar University

Publications and helpful links

General Publications

• International Association of Diabetes and Pregnancy Study Groups Consensus Panel; Metzger BE, Gabbe SG, Persson B, Buchanan TA, Catalano PA, Damm P, Dyer AR, Leiva Ad, Hod M, Kitzmiler JL, Lowe LP, McIntyre HD, Oats JJ, Omori Y, Schmidt MI. International association of diabetes and pregnancy study groups recommendations on the diagnosis and classification of hyperglycemia in pregnancy. Diabetes Care. 2010 Mar;33(3):676-82. doi: 10.2337/dc09-1848. No abstract available.
• Doi SAR, Bashir M, Sheehan MT, Onitilo AA, Chivese T, Ibrahim IM, Beer SF, Furuya-Kanamori L, Abou-Samra AB, McIntyre HD. Unifying the diagnosis of gestational diabetes mellitus: Introducing the NPRP criteria. Prim Care Diabetes. 2022 Feb;16(1):96-101. doi: 10.1016/j.pcd.2021.08.006. Epub 2021 Aug 19.
• Bashir M, Syed A, Furuya-Kanamori L, Musa OAH, Mohamed AM, Skarulis M, Thalib L, Konje JC, Abou-Samra AB, Doi SAR. Core outcomes in gestational diabetes for treatment trials: The Gestational Metabolic Group treatment set. Obes Sci Pract. 2021 Feb 3;7(3):251-259. doi: 10.1002/osp4.480. eCollection 2021 Jun.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: May 1, 2024
• First Submitted That Met QC Criteria: May 3, 2024
• First Posted (Actual): May 7, 2024

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 6, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Obesity; Dysglycemia; Gestational Diabetes Mellitus; IADPSG; NPRP; High-risk Pregnancy
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Disease; Diabetes, Gestational
• Other Study ID Numbers: ARG02-0403-240134

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plans at this point.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No