Gestational Diabetes Mellitus in PregnancyNCT04455880
Shear Wave Elastography in Gestational Diabetes Mellitus
A study testing SWE is a novel noninvasive dynamic ultrasound technique which refers to measurement for quantitative analysis of tissue elasticity in people with Gestational Diabetes Mellitus in Pregnancy, run by Gulsum Uysal at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes Mellitus in Pregnancy
- What is being tested?
- SWE is a novel noninvasive dynamic ultrasound technique which refers to measurement for quantitative analysis of tissue elasticity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 319 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2019to 30 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zeynep Kamil Women and Children Disease Training and Research Hospital
Istanbul, Üsküdar, 34668
About this study
Official title: 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
Read the 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.
- Being tested
- SWE is a novel noninvasive dynamic ultrasound technique which refers to measurement for quantitative analysis of tissue elasticity
- Keywords
- Shear wave elastography, gestational diabetes mellitus, placental stiffness, high risk pregnancy, placenta
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SWE is a novel noninvasive dynamic ultrasound technique which refers to measurement for quantitative analysis of tissue elasticityOther
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
| Study group | Role | What they receive |
|---|---|---|
| GDM with insulin therapy | Active comparator | Singleton pregnancies above 36 gestational weeks diagnosed Gestational Diabetes Mellitus and treated with insulin therapy. Receives: 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. Receives: 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 Receives: Other: SWE is a novel noninvasive dynamic ultrasound technique which refers to measurement for quantitative analysis of tissue elasticity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start15 May 2019
- Primary completion30 Dec 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes Mellitus in PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 319 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulsum Uysal
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Gulsum Uysal, Adana Numune Training and Research Hospital
- Investigators
- Hicran Acar Sirinoglu, MD, Principal investigator, Zeynep Kamil Women and Children Disease Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04455880
- Sponsor's protocol ID
- 49/2019
- Status last verified
- Jul 2020
- First submitted
- 28 Jun 2020
- Last updated
- 2 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Placental Elastographic Values, Fetal and Neonatal Outcomes in Pregnant Women With Gestational Diabetes and Controls
- ClinicalTrials.gov ID
- NCT04455880
- Acronym / sponsor ID
- 49/2019
- Keywords
- Shear wave elastography, gestational diabetes mellitus, placental stiffness, high risk pregnancy, placenta
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 319 participants (actual)
- Lead sponsor
- Gulsum UysalOther government
- Study start
- 15 May 2019 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 2 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| GDM with insulin therapy | Active comparator | Other: SWE is a novel noninvasive dynamic ultrasound technique which refers to measurement for quantitative analysis of tissue elasticitySingleton pregnancies above 36 gestational weeks diagnosed Gestational Diabetes Mellitus and treated with insulin therapy. |
| GDM treated with only diet (without any medical therapy) | Active comparator | Other: SWE is a novel noninvasive dynamic ultrasound technique which refers to measurement for quantitative analysis of tissue elasticitySingleton pregnancies above 36 gestational weeks diagnosed Gestational Diabetes Mellitus and treated with insulin therapy. |
| Non-diabetic Controls | Active comparator | Other: SWE is a novel noninvasive dynamic ultrasound technique which refers to measurement for quantitative analysis of tissue elasticitySingleton non diabetic healthy pregnancies above 36 gestational weeks |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- multiple gestations,
- pregnancies with fetal anomalies,
- morbidly adherent placenta and uterine malformations
- patients with systemic autoimmune diseases,
- patients with high blood pressure,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SWE is a novel noninvasive dynamic ultrasound technique which refers to measurement for quantitative analysis of tissue elasticitySWE 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 | Other | GDM treated with only diet (without any medical therapy), GDM with insulin therapy, Non-diabetic Controls |
Primary outcome
Shear wave elastography in gestational diabetes mellitus
Time frame: 9 months
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
Time frame: 9 months
Cut off values of velocities will be estimated to predict GDM
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hicran Acar Sirinoglu, MD principal investigator
Zeynep Kamil Women and Children Disease Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SWE is a novel noninvasive dynamic ultrasound technique which refers to measurement for quantitative analysis of tissue elasticity in people with Gestational Diabetes Mellitus in Pregnancy, run by Gulsum Uysal at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shear wave elastography in gestational diabetes mellitus (time frame: 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2020.