- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05026840
GDM Screening During COVID Pandemic. IADPSG vs WHO '99 Criteria
Screening of GDM During COVID Pandemic in an Italian Setting. Comparison Between IADPSG and WHO '99 Criteria
All pregnant women who performed an OGTT following Italian Guidelines and then delivered at our University Hospital from march 2020 to march 2021 were prospectively enrolled in this study. Primary outcome of the study was the number of women to whom was diagnosed GDM with only the fasting glucose value (≥ 92 mg/dl), following Italian Diabetes Societies recommendations for COVID 19 pandemic period. In the same time, we prospectively collected the data of women who became diabetic following the criteria of WHO 1999 (fast glucose value ≥ 120 mg/dl, 2 hours later ≥ 140 mg/dl) still in use in some large countries like India. From the clinical charts, we reported the distribution of risk factors for GDM (maternal age ≥ 35 years, family history for diabetes type 2, ethnia, BMI ≥ 25, previous GDM) and clinical outcomes such as hypertensive disorders, preterm birth, macrosomia, intrauterine growth restriction and Caesarean section in emergency.
These data will be compared between the 2 groups consisting in those diagnosed with only IADPSG criteria versus those diagnosed with only WHO '99 criteria.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Messina, Italy
- University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria: Pregnant women who perform GDM screening -
Exclusion Criteria: Twin pregnancies
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Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
IADPSG
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difference in risk factors and clinical outcomes between groups
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WHO '99
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difference in risk factors and clinical outcomes between groups
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
prevalence of women with a diagnosis of GDM following guidelines during COVID pamdemic
Time Frame: from march 2020 to march 2021
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evaluation of fast glucose level in the period recommended for GDM screening following Italian guidelines
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from march 2020 to march 2021
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
GDM diagnosis with IADPSG criteria versus WHO '99 criteria
Time Frame: from March 2020 to March 2021
|
difference in risk factors and clinical outcomes between groups
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from March 2020 to March 2021
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- van-de-l'Isle Y, Steer PJ, Watt Coote I, Cauldwell M. Impact of changes to national UK Guidance on testing for gestational diabetes screening during a pandemic: a single-centre observational study. BJOG. 2021 Apr;128(5):917-920. doi: 10.1111/1471-0528.16482. Epub 2020 Oct 7.
- D'Anna R, Di Benedetto A, Palella S, Miceli A, Romeo P, Corrado F. Screening of GDM during COVID pandemic in an Italian setting: comparison between IADPSG and WHO '99 criteria. Diabetol Metab Syndr. 2022 Oct 31;14(1):164. doi: 10.1186/s13098-022-00936-4.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IADPSG vs WHO '99
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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