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OpenTrials
Completed

NCT Number: NCT05026840

GDM Screening During COVID Pandemic. IADPSG vs 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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

University Hospital

Messina, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Pregnant women who perform GDM screening -

Exclusion criteria

Twin pregnancies

-

Treatment and study plan

GDM screening criteria

Procedure

difference in risk factors and clinical outcomes between groups

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Messina

Other

Registry information

Official study title

Screening of GDM During COVID Pandemic in an Italian Setting. Comparison Between IADPSG and WHO '99 Criteria

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 30, 2021
Registry last updated
May 20, 2022

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.