Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06401629

Outcomes After Unified Versus Standard GDM Diagnosis

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

NPRP criteria

Diagnostic Test

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

Diagnostic Test

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).

Primary outcomes

  1. large for gestational age (LGA)

    Time frame: Through pregnancy completion, an average of 9 months

    infants who weigh > 90th percentile for gestational age

Secondary outcomes

  1. Average plasma glucose

    Time frame: Through pregnancy completion, an average of 9 months

    Report: Group mean and standard deviation (SD); for both pre-prandial and 2 hour postprandial glucose

  2. Glycemic targets unmet

    Time frame: Through pregnancy completion, an average of 9 months

    Reports: Number with any of the following: Need to move to insulin; readmission for poor glycemic control; intervention targets unmet

  3. Adverse events related to treatment

    Time frame: Through pregnancy completion, an average of 9 months

    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)
  4. Total weight gain in pregnancy (kg)

    Time frame: Through pregnancy completion, an average of 9 months

    Report: Group means and SD of total weight gained during pregnancy

  5. Birth weight (newborn's weight at birth)

    Time frame: Through pregnancy completion, an average of 9 months

    Report: Numbers (by group) with LGA as well as group means and SD of continuous birth weight

  6. Hypoglycemia within 1 hour of birth

    Time frame: Through pregnancy completion, an average of 9 months

    Report: Number (by group) with hypoglycemia (<=1.65 mmol/L)

  7. Neonatal composite morbidity and mortality outcome

    Time frame: Through pregnancy completion, an average of 9 months

    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
  8. Assisted labor/delivery (including cesarean)

    Time frame: Through pregnancy completion, an average of 9 months

    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
  9. Preterm delivery

    Time frame: Through pregnancy completion, an average of 9 months

    Report: Number (by group) with delivery at <37 weeks of gestation

  10. Peripartum infection

    Time frame: Through pregnancy completion, an average of 9 months

    Report: Number (by group) of any of chorioamnionitis, urinary tract infections (UTI) or any other maternal infections

  11. Pregnancy induced hypertension (PIH) or pre-eclampsia/ eclampsia

    Time frame: Through pregnancy completion, an average of 9 months

    Report: Number (by group) of all PIH as well as split by

    • Eclampsia/pre-eclampsia
    • Other PIH

Other outcomes

  1. Additional composite outcome

    Time frame: Through pregnancy completion, an average of 9 months

    A composite of PIH, preterm delivery, LGA, NICU admission for >24h, and stillbirth after 24 weeks)

Study contacts

Contact information is provided by the study sponsor or research team.

Mohammed Bashir, MD

CONTACT

[email protected]

Suhail A. Doi, MBBS, PhD

CONTACT

[email protected]

+974 66001271

Sponsors and collaborators

Lead sponsor

Qatar University

Other

Collaborators

  • Hamad Medical Corporation

Registry information

Official study title

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

Acronym: UPDATE-GDM

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
May 7, 2024
Registry last updated
May 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.