Risk Factors and Diagnostic Performance of Predictors as a Screening Technique for Gestational Diabetes Mellitus

Sponsor
King Abdulaziz Medical City (Other)
Overall Status
Completed
CT.gov ID
NCT06109597
Collaborator
(none)
247
1
13.3
18.6

Study Details

Study Description

Brief Summary

Background Gestational diabetes mellitus (GDM) is a condition that can have negative impacts on both mother and baby. Detecting GDM early is crucial, and fasting plasma glucose (FPG) has been suggested as a possible screening method. This retrospective cross-sectional study aims to investigate potential risk factors and complications associated with GDM. Additionally, it aims to establish the diagnostic performance of predictive factors as a screening method for GDM.

Methods Data were collected from the medical records of 247 pregnant women who visited high-risk pregnancy outpatient clinics at King Abdul-Aziz Medical City in Jeddah between 2021 and 2022. The study investigated potential risk factors and complications associated with gestational diabetes mellitus (GDM), including impaired fasting glucose/impaired glucose tolerance (IFG/IGT), family history of diabetes mellitus (DM), and medical conditions. Moreover, the study evaluated the diagnostic performance of potential predictors as screening techniques for gestational diabetes mellitus (GDM).

Condition or Disease Intervention/Treatment Phase
  • Other: 75 g glucose tolerance test

Detailed Description

This study was a hospital-based retrospective cross-sectional study. The study was conducted at the clinic of King Abdul-Aziz Medical City, a tertiary care hospital in Jeddah, Saudi Arabia. Data were collected from the target population through the use of medical records.

Study Population For this study, the investigators looked at all pregnant patients who visited high-risk pregnancy outpatient clinics at King Abdul-Aziz Medical City in Jeddah from 2021 to 2022. Our focus was on singleton pregnant women who received prenatal care services in Obstetrics clinics at King Abdul-Aziz Medical City. However, to ensure accurate and valid results, the investigators excluded pregnant women with diabetes mellitus or autoimmune diseases. By examining this specific population of pregnant women, the investigators aimed to investigate potential risk factors and complications associated with high-risk pregnancies.

Sampling technique and size:

The sampling technique for this study is non-probability consecutive sampling, which will include all pregnant patients who visited high-risk pregnancy outpatient clinics at King Abdul-Aziz Medical City in Jeddah from 2021 to 2022. The study aims to collect data from all members of the target population instead of sampling from a larger population.

Data Collection Technique and Tool The data collection tool was developed and face-validated by two consultants in the field. The tool was designed to collect data from the medical records of the participants, including their fasting blood glucose (FBG) levels and oral glucose tolerance test (OGTT) results. The tool was also used to collect information about the participants' obstetric history, demographic characteristics, and medical conditions

Study Design

Study Type:
Observational
Actual Enrollment :
247 participants
Observational Model:
Other
Time Perspective:
Retrospective
Official Title:
Risk Factors and Diagnostic Performance of Predictors as a Screening Technique for Gestational Diabetes Mellitus: A Retrospective Cross-Sectional Study.
Actual Study Start Date :
May 23, 2022
Actual Primary Completion Date :
May 1, 2023
Actual Study Completion Date :
Jul 2, 2023

Outcome Measures

Primary Outcome Measures

  1. Complications associated with gestational diabetes mellitus [1 year]

    The study investigated potential risk factors and complications associated with gestational diabetes mellitus (GDM), including impaired fasting glucose/impaired glucose tolerance (IFG/IGT), family history of diabetes mellitus (DM), and medical conditions.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Singleton pregnant women who received prenatal care services in Obstetrics clinics at king Abdul-Aziz medical city.
Exclusion Criteria:
  • Pregnant known to have diabetes mellitus.

  • Participant with Autoimmune disease.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fatimah Khobrani Jeddah Saudi Arabia

Sponsors and Collaborators

  • King Abdulaziz Medical City

Investigators

  • Principal Investigator: Fatimah M Khobrani, Associate, KAMC

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
fatimah khobrani, Associate consultant family medicine, King Abdulaziz Medical City
ClinicalTrials.gov Identifier:
NCT06109597
Other Study ID Numbers:
  • fatimahkhobrani
First Posted:
Oct 31, 2023
Last Update Posted:
Oct 31, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 31, 2023