Clinical trial NCT06109597: Risk Factors and Diagnostic Performance of Predictors as a Screening Technique for Gestational Diabetes Mellitus
Official title: Risk Factors and Diagnostic Performance of Predictors as a Screening Technique for Gestational Diabetes Mellitus: A Retrospective Cross-Sectional Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gestational Diabetes
Lead sponsor: King Abdulaziz Medical City
Sponsor class: OTHER_GOV
First posted: 2023-10-31
Enrollment: 247
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

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).

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

Eligibility criteria: 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.

Primary outcomes:
measure: Complications associated with gestational diabetes mellitus
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: Fatimah Khobrani
Study officials:
affiliation: KAMC
name: Fatimah M Khobrani, Associate
role: PRINCIPAL_INVESTIGATOR
References: