Shear Wave Elastography in Gestational Diabetes Mellitus
Condition: Gestational Diabetes Mellitus in Pregnancy
MeSH terms: Diabetes, Gestational; Pregnancy in Diabetics; Diabetes Mellitus
Study type: Interventional

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.
    

Intervention name(s): SWE is a novel noninvasive dynamic ultrasound technique which refers to measurement for quantitative analysis of tissue elasticity
Intervention type(s): Other
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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)
Primary purpose: Other
Keywords: Shear wave elastography; gestational diabetes mellitus; placental stiffness; high risk pregnancy; placenta