NCT06109597

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
247

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 23, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 31, 2023

Completed
Last Updated

October 31, 2023

Status Verified

October 1, 2023

Enrollment Period

11 months

First QC Date

October 15, 2023

Last Update Submit

October 28, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

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

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Singleton pregnant women who received prenatal care services in Obstetrics clinics at king Abdul-Aziz medical city.

You may not qualify if:

  • Pregnant known to have diabetes mellitus.
  • Participant with Autoimmune disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fatimah Khobrani

Jeddah, Saudi Arabia

Location

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Glucose Tolerance Test

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineInvestigative Techniques

Study Officials

  • Fatimah M Khobrani, Associate

    KAMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate consultant family medicine

Study Record Dates

First Submitted

October 15, 2023

First Posted

October 31, 2023

Study Start

May 23, 2022

Primary Completion

May 1, 2023

Study Completion

July 2, 2023

Last Updated

October 31, 2023

Record last verified: 2023-10

Locations