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.
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
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Enrollment
2,650
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).
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).
large for gestational age (LGA)
infants who weigh \> 90th percentile for gestational age
Time frame: 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
Time frame: Through pregnancy completion, an average of 9 months
Glycemic targets unmet
Reports: Number with any of the following: Need to move to insulin; readmission for poor glycemic control; intervention targets unmet
Time frame: 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: 1. Maternal hypoglycemia (glucose \< 4 mmol/L or who received inter-venous glucose rescue) 2. Others (excluding hypoglycemia)
Time frame: 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
Time frame: 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
Time frame: Through pregnancy completion, an average of 9 months
Hypoglycemia within 1 hour of birth
Report: Number (by group) with hypoglycemia (\<=1.65 mmol/L)
Time frame: 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: 1. NICU admission \> 24 hours 2. Neonatal death (within 28 days of birth) 3. Stillbirth
Time frame: 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: 1. Non-cesarean: any of induction/augmentation/vacuum extraction/operative vaginal delivery etc. 2. Elective/Emergency Cesarean Section 3. Primary/repeated Cesarean Section
Time frame: Through pregnancy completion, an average of 9 months
Preterm delivery
Report: Number (by group) with delivery at \<37 weeks of gestation
Time frame: 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
Time frame: 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 1. Eclampsia/pre-eclampsia 2. Other PIH
Time frame: Through pregnancy completion, an average of 9 months
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