Shear Wave Elastography in Gestational Diabetes Mellitus

NCT04455880 | Completed DMC

• 1 other identifier: 49/2019
• Study Type: interventional
• Target: 319
• Locations: 1 country
• Sites: 1

Brief Summary

Our aim was to investigate and compare placental elasticity by using Shear wave elastography (SWE) in patients with gestational diabetes mellitus (GDM) with and without insulin to non-diabetic controls. This prospective study included 319 pregnant patients. Three groups were created as follows: Group 1 (n= 79, GDM with insulin therapy), Group 2 (n=90, GDM with only diet) and Group 3 (n= 150, healthy controls) All patients were above 36 gestational weeks with anterior placenta. Totally six measurements including the central and peripheral parts (right, left) of the placenta both from maternal and fetal sites were obtained with SWE. Demographic, obstetrics, fetal and perinatal features were also compared. Receiver operating characteristic analysis was plotted and cut-off of elastographic velocity values were noted

Conditions

Gestational Diabetes Mellitus in Pregnancy

Keywords

Shear wave elastography; gestational diabetes mellitus; placental stiffness; high risk pregnancy; placenta

Outcome Measures

Primary Outcomes (2)

• Shear wave elastography in gestational diabetes mellitus

  To investigate and compare placental elasticity by using Shear wave elastography (SWE) in patients with gestational diabetes mellitus (GDM) with and without insulin to non-diabetic controls.

  9 months

• Prediction and differentiation of GDM and prognosis with Shear wave elastography velocity cut-offs

  Cut off values of velocities will be estimated to predict GDM

  9 months

Study Arms (3)

GDM with insulin therapy

ACTIVE COMPARATOR

Singleton pregnancies above 36 gestational weeks diagnosed Gestational Diabetes Mellitus and treated with insulin therapy.

Other: SWE is a novel noninvasive dynamic ultrasound technique which refers to measurement for quantitative analysis of tissue elasticity

GDM treated with only diet (without any medical therapy)

ACTIVE COMPARATOR

Singleton pregnancies above 36 gestational weeks diagnosed Gestational Diabetes Mellitus and treated with insulin therapy.

Other: SWE is a novel noninvasive dynamic ultrasound technique which refers to measurement for quantitative analysis of tissue elasticity

Non-diabetic Controls

ACTIVE COMPARATOR

Singleton non diabetic healthy pregnancies above 36 gestational weeks

Other: SWE is a novel noninvasive dynamic ultrasound technique which refers to measurement for quantitative analysis of tissue elasticity

Interventions

SWE is a novel noninvasive dynamic ultrasound technique which refers to measurement for quantitative analysis of tissue elasticity OTHER

SWE is a novel noninvasive dynamic ultrasound technique which refers to measurement for quantitative analysis of tissue elasticity. The stiffer the tissue, the higher shear wave velocity is measured. Elastographic examinations were performed by physicians using Samsung HS70A ultrasound system with a Samsung CA1-7A convex transducer and S-Shear wave technique. During the examination, patients were lying in supine position, breathing levels kept steady to prevent noise and artifacts and minimum pressure were applied on the transducer to eliminate misleading tissue compression. A region of interest (ROI) box of 10 × 10 mm was positioned on placenta and six measurements were obtained from central and peripheral zones of placenta while avoiding vascular structures

GDM treated with only diet (without any medical therapy); GDM with insulin therapy; Non-diabetic Controls

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Singleton 36 weeks of gestation with anterior placenta
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Singleton pregnant women who applied for third trimester prenatal examination
• gestational weeks and above with anterior placenta
• Diagnosed Gestational Diabetes Mellitus with 100 gr oral glucose tolerance test
• Using insulin therapy or diet without any anti-diabetic medication.

You may not qualify if:

• multiple gestations,
• pregnancies with fetal anomalies,
• morbidly adherent placenta and uterine malformations
• patients with systemic autoimmune diseases,
• patients with high blood pressure,
• patients with smoking history

Sponsors & Collaborators

• Gulsum Uysal: lead

Study Sites (1)

Zeynep Kamil Women and Children Disease Training and Research Hospital

Istanbul, Üsküdar, 34668, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes, Gestational

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

Study Officials

• Hicran Acar Sirinoglu, MD

  Zeynep Kamil Women and Children Disease Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor in Obstetrics and Gynecology Department

Model Details: Group 1 (n= 79, GDM with insulin therapy), Group 2 (n=90, GDM with only diet), Group 3 (n= 150, healthy controls) All patients were above 36 gestational weeks with anterior placenta.

Study Record Dates

• First Submitted: June 28, 2020
• First Posted: July 2, 2020
• Study Start: May 15, 2019
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: July 2, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)