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

May 6, 2024 updated by: Suhail A. Doi, Qatar University

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2650

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Suhail A. Doi, MBBS, PhD
  • Phone Number: +974 66001271
  • Email: sdoi@qu.edu.qa

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
large for gestational age (LGA)
Time Frame: Through pregnancy completion, an average of 9 months
infants who weigh > 90th percentile for gestational age
Through pregnancy completion, an average of 9 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Through pregnancy completion, an average of 9 months
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:

  1. Maternal hypoglycemia (glucose < 4 mmol/L or who received inter-venous glucose rescue)
  2. Others (excluding hypoglycemia)
Through pregnancy completion, an average of 9 months
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)
Through pregnancy completion, an average of 9 months
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:

  1. Non-cesarean: any of induction/augmentation/vacuum extraction/operative vaginal delivery etc.
  2. Elective/Emergency Cesarean Section
  3. Primary/repeated Cesarean Section
Through pregnancy completion, an average of 9 months
Preterm delivery
Time Frame: Through pregnancy completion, an average of 9 months
Report: Number (by group) with delivery at <37 weeks of gestation
Through pregnancy completion, an average of 9 months
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
Through pregnancy completion, an average of 9 months
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
Through pregnancy completion, an average of 9 months
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
Through pregnancy completion, an average of 9 months
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:

  1. NICU admission > 24 hours
  2. Neonatal death (within 28 days of birth)
  3. Stillbirth
Through pregnancy completion, an average of 9 months
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
Through pregnancy completion, an average of 9 months
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

  1. Eclampsia/pre-eclampsia
  2. Other PIH
Through pregnancy completion, an average of 9 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
Through pregnancy completion, an average of 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Qatar University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hamad Medical Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Suhail A. Doi, MBBS, PhD, Qatar University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 1, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 7, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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