Shear Wave Elastography in Gestational Diabetes Mellitus

The Comparison of Placental Elastographic Values, Fetal and Neonatal Outcomes in Pregnant Women With Gestational Diabetes and Controls

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

Study Overview

• Status: Completed
• Conditions: Gestational Diabetes Mellitus in Pregnancy
• Intervention / Treatment: Other: SWE is a novel noninvasive dynamic ultrasound technique which refers to measurement for quantitative analysis of tissue elasticity

Detailed Description

This prospective study included singleton pregnant women aged between 18-45 years who applied for third trimester prenatal examination (36 gestational weeks and above) between May 2019 and December 2019 at Women and Children Disease Training and Research Hospital, Istanbul, Turkey. Ethical documents including Declaration of Helsinki were approved by local institutional review board (Approval number:49/2019) and a written informed consent was obtained from all patients. The study participants were divided into three groups according to treatments. While Group 1 consisted of patients with GDM using insulin therapy (GDM A2), patients with GDM treated with only diet (without any medical therapy) created Group 2 (GDM A1). Group 3 included healthy controls. Insulin therapy was initiated when target cut-off values were exceeded according to Carpenter and Coustan criteria. Patients with anterior placenta were included in the study because the effectiveness of the method decreased. Gestational age was recorded regarding last menstrual period and was checked in all participants by using a first trimester ultrasound report. All GDM patients were followed up in perinatology clinic and timing of delivery was organized individually basically on obstetrical indications. Ultrasonographic evaluation and SWE method were performed by single perinatologist 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. Considering the disc-like structure of the placenta measurement areas were divided into six regions as follows: maternal right, maternal central, maternal left, fetal right, fetal central and fetal left. All measurements taken from different zones were recorded individually along with the mean value generated using IQR method. Through this approach, datasets were established not just for the auto-calculated mean value but also zone specific values for further analysis. All measurements were obtained in both kilopascal (kPa) and m/s formats.

• Study Type: Interventional
• Enrollment (Actual): 319
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Üsküdar
    • Istanbul, Üsküdar, Turkey, 34668
      • Zeynep Kamil Women and Children Disease Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Singleton pregnant women who applied for third trimester prenatal examination
• 36 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: GDM with insulin therapy; 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; 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
Active Comparator: GDM treated with only diet (without any medical therapy); 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; 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
Active Comparator: Non-diabetic Controls; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Gulsum Uysal
• Investigators: Principal Investigator: Hicran Acar Sirinoglu, MD, Zeynep Kamil Women and Children Disease Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2019
• Primary Completion (Actual): December 30, 2019
• Study Completion (Actual): December 30, 2019

Study Registration Dates

• First Submitted: June 28, 2020
• First Submitted That Met QC Criteria: July 1, 2020
• First Posted (Actual): July 2, 2020

Study Record Updates

• Last Update Posted (Actual): July 2, 2020
• Last Update Submitted That Met QC Criteria: July 1, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: placenta; gestational diabetes mellitus; high risk pregnancy; Shear wave elastography; placental stiffness
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Diabetes, Gestational; Pregnancy in Diabetics
• Other Study ID Numbers: 49/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No