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

NCT ID: NCT06109597

Last Updated: 2023-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

247 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-23

Study Completion Date

2023-07-02

Brief Summary

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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

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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

Conditions

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Gestational Diabetes

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Interventions

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75 g glucose tolerance test

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

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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King Abdulaziz Medical City

OTHER_GOV

Sponsor Role lead

Responsible Party

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fatimah khobrani

Associate consultant family medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fatimah M Khobrani, Associate

Role: PRINCIPAL_INVESTIGATOR

KAMC

Locations

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Fatimah Khobrani

Jeddah, , Saudi Arabia

Site Status

Countries

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Saudi Arabia

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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fatimahkhobrani

Identifier Type: -

Identifier Source: org_study_id