GDM Screening During COVID Pandemic. IADPSG vs WHO '99 Criteria

May 19, 2022 updated by: Rosario D'anna, University of Messina

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

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

120

Contacts and Locations

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

Study Locations

  • Italy
      • Messina, Italy
        • University Hospital

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

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

All pregnant women who in a 12-month period perform GDM screening and then deliver at our University Hospital

Description

Inclusion Criteria: Pregnant women who perform GDM screening -

Exclusion Criteria: Twin pregnancies

-

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
IADPSG
Procedure: GDM screening criteria
difference in risk factors and clinical outcomes between groups
WHO '99
Procedure: GDM screening criteria
difference in risk factors and clinical outcomes between groups

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
evaluation of fast glucose level in the period recommended for GDM screening following Italian guidelines
from march 2020 to march 2021

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
from March 2020 to March 2021

Collaborators and Investigators

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

Sponsor

University of Messina

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 (Actual)

March 1, 2020

Primary Completion (Actual)

March 31, 2021

Study Completion (Actual)

September 30, 2021

Study Registration Dates

First Submitted

August 27, 2021

First Submitted That Met QC Criteria

August 27, 2021

First Posted (Actual)

August 30, 2021

Study Record Updates

Last Update Posted (Actual)

May 20, 2022

Last Update Submitted That Met QC Criteria

May 19, 2022

Last Verified

May 1, 2022

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)?

NO

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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