Gestational DiabetesUPDATE-GDMNCT06401629
Outcomes After Unified Versus Standard GDM Diagnosis
A study testing NPRP criteria and IADPSG criteria in people with Gestational Diabetes and Diagnosis, run by Qatar University.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Gestational Diabetes, Diagnosis, Pregnancy
- What is being tested?
- NPRP criteria and IADPSG criteria
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,650 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Mohammed Bashir, MD contact
About this study
Official title: 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.
Read the 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.
- Conditions
- Gestational Diabetes, Diagnosis, Pregnancy
- Being tested
- NPRP criteria, IADPSG criteria
- Keywords
- Gestational Diabetes Mellitus, IADPSG, NPRP, Obesity, Dysglycemia, High-risk Pregnancy
- Medical subject headings
- Diabetes, Gestational, Disease, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NPRP criteriaDiagnostic 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 criteriaDiagnostic 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).
| Study group | Role | What they receive |
|---|---|---|
| National Priorities Research Program (NPRP) diagnostic criterion | Experimental | Interventional diagnostic strategy Receives: Diagnostic Test: NPRP criteria |
| International Association of Diabetes and Pregnancy Study Groups (IADPSG) diagnostic criterion | Active comparator | Control diagnostic strategy Receives: Diagnostic Test: IADPSG criteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
large for gestational age (LGA)
infants who weigh > 90th percentile for gestational age
Measured: Through pregnancy completion, an average of 9 months
Secondary outcomes (11)
Average plasma glucose
Report: Group mean and standard deviation (SD); for both pre-prandial and 2 hour postprandial glucose
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: Through pregnancy completion, an average of 9 months
Hypoglycemia within 1 hour of birth
Report: Number (by group) with hypoglycemia (<=1.65 mmol/L)
Measured: 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
Measured: 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
Measured: Through pregnancy completion, an average of 9 months
Preterm delivery
Report: Number (by group) with delivery at <37 weeks of gestation
Measured: 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
Measured: 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
Measured: Through pregnancy completion, an average of 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start1 Jan 2025 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will be designed as a multicentre, two-arm, parallel, pragmatic, randomized controlled trial conducted at two participating hospitals in Qatar. This design allows for an assessment of interventions in real-world settings and offers practical insights into the clinical utility of different diagnostic criteria. All pregnancies will be randomly assigned to the NPRP or IADPSG approach (1:1 ratio) at their first prenatal visit using an electronically generated random assignment procedure; this assignment will be provided to the lab within CERNER at the time of reporting GDM screening results (typically done at 24-28 weeks' gestation). If screening was ordered more than once, the same assigned result type will be presented to providers each time.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 2,650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qatar University
- Sponsor type
- University, hospital or other
- Collaborators
- Hamad Medical Corporation
- Responsible party
- Principal investigator, Suhail A. Doi, Qatar University
- Investigators
- Suhail A. Doi, MBBS, PhD, Principal investigator, Qatar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06401629
- Sponsor's protocol ID
- ARG02-0403-240134
- Acronym
- UPDATE-GDM
- Status last verified
- May 2024
- First submitted
- 1 May 2024
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plans at this point.
Publications
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.
PubMed 34419366International 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.
PubMed 20190296Bashir 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.
PubMed 34123392
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The UPDATE-GDM Study: OUtcomes After NPRP anD ConventionAl CriTEria for GDM Diagnosis: A Pragmatic Randomised Trial
- ClinicalTrials.gov ID
- NCT06401629
- Acronym / sponsor ID
- UPDATE-GDM / ARG02-0403-240134
- Conditions
- Gestational Diabetes, Diagnosis, Pregnancy
- Keywords
- Gestational Diabetes Mellitus, IADPSG, NPRP, Obesity, Dysglycemia, High-risk Pregnancy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,650 participants (estimated)
- Lead sponsor
- Qatar UniversityUniversity, hospital or other
- Collaborators
- Hamad Medical Corporation
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 7 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This study will be designed as a multicentre, two-arm, parallel, pragmatic, randomized controlled trial conducted at two participating hospitals in Qatar. This design allows for an assessment of interventions in real-world settings and offers practical insights into the clinical utility of different diagnostic criteria. All pregnancies will be randomly assigned to the NPRP or IADPSG approach (1:1 ratio) at their first prenatal visit using an electronically generated random assignment procedure; this assignment will be provided to the lab within CERNER at the time of reporting GDM screening results (typically done at 24-28 weeks' gestation). If screening was ordered more than once, the same assigned result type will be presented to providers each time.
| Arm | Type | Receives |
|---|---|---|
| National Priorities Research Program (NPRP) diagnostic criterion | Experimental | Diagnostic Test: NPRP criteriaInterventional diagnostic strategy |
| International Association of Diabetes and Pregnancy Study Groups (IADPSG) diagnostic criterion | Active comparator | Diagnostic Test: IADPSG criteriaControl diagnostic strategy |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NPRP criteriaUnder 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). | Diagnostic test | National Priorities Research Program (NPRP) diagnostic criterion |
| IADPSG criteriaThe 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). | Diagnostic test | International Association of Diabetes and Pregnancy Study Groups (IADPSG) diagnostic criterion |
Primary outcome
large for gestational age (LGA)
Time frame: Through pregnancy completion, an average of 9 months
infants who weigh > 90th percentile for gestational age
11 secondary outcomes
Average plasma glucose
Time frame: Through pregnancy completion, an average of 9 months
Glycemic targets unmet
Time frame: Through pregnancy completion, an average of 9 months
Adverse events related to treatment
Time frame: Through pregnancy completion, an average of 9 months
Total weight gain in pregnancy (kg)
Time frame: 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
Hypoglycemia within 1 hour of birth
Time frame: Through pregnancy completion, an average of 9 months
Neonatal composite morbidity and mortality outcome
Time frame: Through pregnancy completion, an average of 9 months
Assisted labor/delivery (including cesarean)
Time frame: Through pregnancy completion, an average of 9 months
Preterm delivery
Time frame: Through pregnancy completion, an average of 9 months
Peripartum infection
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Background: PubMed 34419366Doi 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.
- Background: PubMed 20190296International 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.
- Background: PubMed 34123392Bashir 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.
- Individual participant dataSharing planned: No. No plans at this point.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohammed Bashir, MD contact
Suhail A. Doi, MBBS, PhD principal investigator
Qatar University
Questions about this trial
What is this clinical trial studying?
A study testing NPRP criteria and IADPSG criteria in people with Gestational Diabetes and Diagnosis, run by Qatar University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Suhail A. Doi, MBBS, PhD (+974 66001271, sdoi@qu.edu.qa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
large for gestational age (LGA) (time frame: Through pregnancy completion, an average of 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06401629, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.