The Value of Second-trimester Uterine Artery Doppler Analysis in the Prediction of GDM in a Low- Risk Population

NCT05488197 | Completed

• 1 other identifier: PS-GDM-2022
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

Brief Summary

In the current literature, there are not enough studies related to the use of uterine artery Doppler indices in the second trimester for the prediction of GDM. Considering that it may be useful in the prediction of GDM in low-risk patient groups for GDM, it was found useful to consider uterine artery Doppler analysis within the scope of this study.In this study, the investigators aimed to assess the value of second-trimester uterine artery Doppler analysis in the prediction of GDM in a low- risk population.

Conditions

Gestational Diabetes

Outcome Measures

Primary Outcomes (1)

• Uterine artery Doppler ultrasonography in gestational diabetes mellitus

  To investigate and compare uterine artery pulsatility index by Doppler ultrasonography in patients with gestational diabetes mellitus (GDM) and without to non-diabetic controls.

  Through study completion, an average of 18 months

Secondary Outcomes (1)

• Prediction of GDM with uterine artery pulsatility index cut-offs

  Through study completion, an average of 18 months

Study Arms (2)

Group 1 participants with gestational diabetes

Other: uterine artery doppler at 18-23 weeks of pregnancy

Group 2 participants without gestational diabetes

Other: uterine artery doppler at 18-23 weeks of pregnancy

Interventions

uterine artery doppler at 18-23 weeks of pregnancy OTHER

uterine artery doppler at 18-23 weeks of pregnancy

Group 1 participants with gestational diabetes; Group 2 participants without gestational diabetes

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Pregnant women with or without Gestational Dibetes in low- risk population

You may qualify if:

• Pregnant women with or without Gestational Diabetes in low- risk population

You may not qualify if:

• Pregestational Diabetes
• Preeclampsia
• Intrauterine growth restriction
• Chronic Maternal Disease

Sponsors & Collaborators

• Haseki Training and Research Hospital: lead

Study Sites (1)

Haseki Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Pregnancy

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: August 4, 2022
• Study Start: June 10, 2021
• Primary Completion: June 30, 2022
• Study Completion: July 10, 2022
• Last Updated: August 4, 2022

Record last verified: 2022-08

Locations

TU (1)