Outcomes After Unified Versus Standard GDM Diagnosis

Pregnancy Clinical Trial

— UPDATE-GDM  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06401629
• Other study ID #: ARG02-0403-240134
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2025
• Est. completion date: June 1, 2027

Study information

• Verified date: May 2024
• Source: Qatar University
• Contact: Suhail A. Doi, MBBS, PhD
• Phone: +974 66001271
• Email: sdoi[@]qu.edu.qa
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2650
• Est. completion date: June 1, 2027
• Est. primary completion date: June 1, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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).

Related Conditions & MeSH terms

• Diabetes, Gestational
• Diagnosis
• Disease
• Gestational Diabetes
• Pregnancy

Intervention

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).
• 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).

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Qatar University	Hamad Medical Corporation

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	large for gestational age (LGA)	infants who weigh > 90th percentile for gestational age	Through pregnancy completion, an average of 9 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Hypoglycemia within 1 hour of birth	Report: Number (by group) with hypoglycemia (<=1.65 mmol/L)	Through pregnancy completion, an average of 9 months
Secondary	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
Secondary	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
Secondary	Preterm delivery	Report: Number (by group) with delivery at <37 weeks of gestation	Through pregnancy completion, an average of 9 months
Secondary	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
Secondary	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