Shear Wave Elastography in Gestational Diabetes Mellitus
Primary Purpose
Gestational Diabetes Mellitus in Pregnancy
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
SWE is a novel noninvasive dynamic ultrasound technique which refers to measurement for quantitative analysis of tissue elasticity
Sponsored by
About this trial
This is an interventional other trial for Gestational Diabetes Mellitus in Pregnancy focused on measuring Shear wave elastography, gestational diabetes mellitus, placental stiffness, high risk pregnancy, placenta
Eligibility Criteria
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
Sites / Locations
- Zeynep Kamil Women and Children Disease Training and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
GDM with insulin therapy
GDM treated with only diet (without any medical therapy)
Non-diabetic Controls
Arm Description
Singleton pregnancies above 36 gestational weeks diagnosed Gestational Diabetes Mellitus and treated with insulin therapy.
Singleton pregnancies above 36 gestational weeks diagnosed Gestational Diabetes Mellitus and treated with insulin therapy.
Singleton non diabetic healthy pregnancies above 36 gestational weeks
Outcomes
Primary Outcome Measures
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.
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04455880
Brief Title
Shear Wave Elastography in Gestational Diabetes Mellitus
Official Title
The Comparison of Placental Elastographic Values, Fetal and Neonatal Outcomes in Pregnant Women With Gestational Diabetes and Controls
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
May 15, 2019 (Actual)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
December 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gulsum Uysal
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes Mellitus in Pregnancy
Keywords
Shear wave elastography, gestational diabetes mellitus, placental stiffness, high risk pregnancy, placenta
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
319 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GDM with insulin therapy
Arm Type
Active Comparator
Arm Description
Singleton pregnancies above 36 gestational weeks diagnosed Gestational Diabetes Mellitus and treated with insulin therapy.
Arm Title
GDM treated with only diet (without any medical therapy)
Arm Type
Active Comparator
Arm Description
Singleton pregnancies above 36 gestational weeks diagnosed Gestational Diabetes Mellitus and treated with insulin therapy.
Arm Title
Non-diabetic Controls
Arm Type
Active Comparator
Arm Description
Singleton non diabetic healthy pregnancies above 36 gestational weeks
Intervention Type
Other
Intervention Name(s)
SWE is a novel noninvasive dynamic ultrasound technique which refers to measurement for quantitative analysis of tissue elasticity
Intervention Description
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
Primary Outcome Measure Information:
Title
Shear wave elastography in gestational diabetes mellitus
Description
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.
Time Frame
9 months
Title
Prediction and differentiation of GDM and prognosis with Shear wave elastography velocity cut-offs
Description
Cut off values of velocities will be estimated to predict GDM
Time Frame
9 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Singleton 36 weeks of gestation with anterior placenta
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hicran Acar Sirinoglu, MD
Organizational Affiliation
Zeynep Kamil Women and Children Disease Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zeynep Kamil Women and Children Disease Training and Research Hospital
City
Istanbul
State/Province
Üsküdar
ZIP/Postal Code
34668
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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Shear Wave Elastography in Gestational Diabetes Mellitus
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