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

Risk Factors and Diagnostic Performance of Predictors as a Screening Technique for Gestational Diabetes Mellitus: A Retrospective Cross-Sectional Study.

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).

Study Overview

• Status: Completed
• Conditions: Gestational Diabetes
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 247

Contacts and Locations

Study Locations

• Saudi Arabia
  • Jeddah, Saudi Arabia
    • Fatimah Khobrani

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

All pregnant patients who attend high risk pregnancy outpatient's clinic at national guard hospital in Jeddah during 2021-2022.

Dependent Variable:

OGTT - Fasting Blood Glucose - Weight - Pregestational BMI

Independent Variable(s):

Age, Gender, Medication, Gestational age, Chronic diseases, Family history, Past gyne and medical history.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications associated with gestational diabetes mellitus	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.	1 year

Collaborators and Investigators

• Sponsor: King Abdulaziz Medical City
• Investigators: Principal Investigator: Fatimah M Khobrani, Associate, KAMC

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2022
• Primary Completion (Actual): May 1, 2023
• Study Completion (Actual): July 2, 2023

Study Registration Dates

• First Submitted: October 15, 2023
• First Submitted That Met QC Criteria: October 28, 2023
• First Posted (Actual): October 31, 2023

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 28, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Diabetes, Gestational
• Other Study ID Numbers: fatimahkhobrani

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No