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

Sponsor
University of Messina (Other)
Overall Status
Completed
CT.gov ID
NCT05026840
Collaborator
(none)
120
1
19
6.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: GDM screening criteria

Study Design

Study Type:
Observational
Actual Enrollment :
120 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Screening of GDM During COVID Pandemic in an Italian Setting. Comparison Between IADPSG and WHO '99 Criteria
Actual Study Start Date :
Mar 1, 2020
Actual Primary Completion Date :
Mar 31, 2021
Actual Study Completion Date :
Sep 30, 2021

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. GDM diagnosis with IADPSG criteria versus WHO '99 criteria [from March 2020 to March 2021]

    difference in risk factors and clinical outcomes between groups

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No

Inclusion Criteria: Pregnant women who perform GDM screening -

Exclusion Criteria: Twin pregnancies

-

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital Messina Italy

Sponsors and Collaborators

  • University of Messina

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rosario D'anna, full professor of obstetrics and gynecology, University of Messina
ClinicalTrials.gov Identifier:
NCT05026840
Other Study ID Numbers:
  • IADPSG vs WHO '99
First Posted:
Aug 30, 2021
Last Update Posted:
May 20, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of May 20, 2022