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

Completed

• Conditions: GDM Screening During COVID Pandemic; Comparison Between IADPSG vs WHO '99 Criteria
• Interventions: Procedure: GDM screening criteria

• Registration Number: NCT05026840
• Lead Sponsor: University of Messina

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-01
• Primary Completion: 2021-03-31
• Study First Submitted: 2021-08-27
• Study First Submitted QC: 2021-08-27
• Study First Posted: 2021-08-30
• Study Completion: 2021-09-30
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-19
• Last Update Posted: 2022-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

Pregnant women who perform GDM screening -

Exclusion Criteria

Twin pregnancies

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
WHO '99	GDM screening criteria	-
IADPSG	GDM screening criteria	-

Primary Outcome Measures

Name	Time	Method
prevalence of women with a diagnosis of GDM following guidelines during COVID pamdemic	from march 2020 to march 2021	evaluation of fast glucose level in the period recommended for GDM screening following Italian guidelines

Secondary Outcome Measures

Name	Time	Method
GDM diagnosis with IADPSG criteria versus WHO '99 criteria	from March 2020 to March 2021	difference in risk factors and clinical outcomes between groups

Trial Locations

Locations (1)

University Hospital; 🇮🇹 Messina, Italy