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

Gestational Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06109597
• Other study ID #: fatimahkhobrani
• Status: Completed
• Start date: May 23, 2022
• Est. completion date: July 2, 2023

Study information

• Verified date: October 2023
• Source: King Abdulaziz Medical City
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 247
• Est. completion date: July 2, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes

Intervention

Other:
• 75 g glucose tolerance test
Pregnant patient who visited obstetric clinic , who did 75 g glucose tolerance test

Locations

Country	Name	City	State
Saudi Arabia	Fatimah Khobrani	Jeddah

Sponsors (1)

Lead Sponsor	Collaborator
King Abdulaziz Medical City

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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