Gestational DiabetesNCT03654521
Fetal Interventricular Septum Thickness and Maternal Gestational Diabetes Control
A study testing Fetal interventricular septum thickness in people with Gestational Diabetes, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
Glucose intolerance and gestational diabetes are common complications of pregnancy. Their prevalence varies worldwide secondary to differences in screening practices (one-step versus two-step approach) and population characteristics (increased maternal age, body mass index, ethnicity). Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- Fetal interventricular septum thickness
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Aug 2018to 31 Dec 2020
- 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 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Study group - women between 24 - 34 weeks' gestation who were diagnosed with gestational diabetes mellitus or known with type I or type II diabetes mellitus.
- Control group - women between 24 - 34 weeks' gestation who do not have diabetes.
Who cannot join
- women who did not complete a glucose challenge test, smoking, underlying cardiac or respiratory illness, fetal growth restriction, medicated hypertension disorder of pregnancy, multiple pregnancy, use of steroids for lung maturation in the current pregnancy and known major congenital anomalies.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Rambam health care campus
Haifa
Yaniv Zipori, MD, 0587966963, y_zipori@rambam.health.gov.il
About this study
Glucose intolerance and gestational diabetes are common complications of pregnancy. Their prevalence varies worldwide secondary to differences in screening practices (one-step versus two-step approach) and population characteristics (increased maternal age, body mass index, ethnicity). Gestational diabetes mellitus is associated with increased incidence of macrosomia, operative vaginal delivery, shoulder dystocia, cesarean delivery, metabolic complications in the newborn and long-term risk of developing type II diabetes mellitus (HAPO 2008).
Early diagnosis and management of gestational diabetes mellitus, including dietary advice and insulin, improves maternal and fetal outcomes (Crowther 2005, Hartling 2013). Various strategies have been tested prenatally to detect those fetuses that might be adversely affected by gestational diabetes mellitus. For instance, the abdominal circumference measurement during routine fetal biometry was used successfully to identify pregnancies with a higher risk of fetal macrosomia (Schaefer-Graf 2003, De Reu 2008, Rosati 2010). In recent years, the fetal interventricular septum thickness, as detected by two-dimensional ultrasound, was shown to be significantly thicker in the presence of gestational diabetes mellitus, independently of maternal glycemic control, when compared to pregnancies with no gestational diabetes mellitus (Ren 2011, Garg 2014).
Current guidelines focus on normalisation of maternal blood glucose concentration. Thus far no study has addressed whether measurement of the fetal interventricular septum thickness can predict adverse pregnancy outcome in euglycemic women with gestational diabetes mellitus.
Read the detailed description
Rational for the study If fetal interventricular septum hypertrophy in pregnancies with gestational diabetes mellitus appears prior to either fetal abdominal circumference measurement > 90th percentile or the abnormal maternal glucose levels, then future management of women with gestational diabetes mellitus might be targeted earlier at these pregnancies to ensure a more favorable outcome.
Objective To determine the thickness of fetal interventricular septum in women with and without gestational diabetes mellitus and correlates it with perinatal outcome.
Methods Study design This is a prospective study at Rambam Health Care Campus. Inclusion / Exclusion criteria
- Inclusion Study group - women between 24 - 34 weeks' gestation who were diagnosed with gestational diabetes mellitus or known with type I or type II diabetes mellitus. Control group - women between 24 - 34 weeks' gestation who do not have diabetes.
- Exclusion (that might affect directly or indirectly the fetal cardiac function) - women who did not complete a glucose challenge test, smoking, underlying cardiac or respiratory illness, fetal growth restriction, medicated hypertension disorder of pregnancy, multiple pregnancy, use of steroids for lung maturation in the current pregnancy and known major congenital anomalies.
Study population Women who meet the above inclusion criteria will be asked to participate in the study, and will be asked to provide a written informed consent. Both groups, the study and control group, will be recruited when attending their routine prenatal care in the prenatal clinics at Rambam Health Care Campus. Eligible woman will undergo ultrasound examination as they would normally do in each visit. This study, under no circumstances, will alter the participants routine care.
Data Collection
- Maternal and fetal characteristics Data related to the fetomaternal antenatal, intrapartum and postpartum course will be recorded prospectively (Appendix 1).
- Ultrasound assessment Basic transabdominal two-dimensional ultrasound examination using B-mode (either Samsung or Voluson E8), will be carried out first to assess fetal growth and well-being. This is to be continued with a more detailed ultrasound, with a specific focus on the fetal interventricular septum. The entire length of the study, dependent on fetal lie, is expected to take around 15 min. The results of the assessment of fetal growth and well-being will be provided to the patient.
The measurement of the fetal interventricular septum will be as follow (Figure 1 below); maternal suspended respiration, without fetal movement or breathing, level of the 4-chamber view with adequate magnification of the fetal heart (50% of the screen), midpoint of interventricular septum with cine loop to end-diastolic (maximum ventricular filling), and average of 3 measurements (Ren 2011, Garg 2014).
- Conditions
- Gestational Diabetes
- Being tested
- Fetal interventricular septum thickness
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fetal interventricular septum thicknessDiagnostic test
Two-dimensional ultrasound fetal cardiac imaging test
| Study group | Role | What they receive |
|---|---|---|
| Diabetes group | Active comparator | Women with gestational or pre-gestational diabetes mellitus. Receives: Diagnostic Test: Fetal interventricular septum thickness |
| Control group | Active comparator | Women without gestational or pre-gestational diabetes mellitus. Receives: Diagnostic Test: Fetal interventricular septum thickness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fetal interventricular septum thickness
Differences in fetal interventricular septum thickness in both women with gestational or pre-gestational diabetes mellitus and women without gestational or pre-gestational diabetes mellitus.
Measured: Between 24-34 weeks of gestation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start1 Aug 2018
- Primary completion15 Jul 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yaniv Zipori MD, Rambam Health Care Campus
- Investigators
- Yaniv Zipori, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03654521
- Sponsor's protocol ID
- 0580-17-RMB
- Status last verified
- Aug 2018
- First submitted
- 30 Aug 2018
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal Interventricular Septum Thickness and Maternal Gestational Diabetes Control
- ClinicalTrials.gov ID
- NCT03654521
- Acronym / sponsor ID
- 0580-17-RMB
- Conditions
- Gestational Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 15 Jul 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 31 Aug 2018 (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.
Glucose intolerance and gestational diabetes are common complications of pregnancy. Their prevalence varies worldwide secondary to differences in screening practices (one-step versus two-step approach) and population characteristics (increased maternal age, body mass index, ethnicity). Gestational diabetes mellitus is associated with increased incidence of macrosomia, operative vaginal delivery, shoulder dystocia, cesarean delivery, metabolic complications in the newborn and long-term risk of developing type II diabetes mellitus (HAPO 2008).
Early diagnosis and management of gestational diabetes mellitus, including dietary advice and insulin, improves maternal and fetal outcomes (Crowther 2005, Hartling 2013). Various strategies have been tested prenatally to detect those fetuses that might be adversely affected by gestational diabetes mellitus. For instance, the abdominal circumference measurement during routine fetal biometry was used successfully to identify pregnancies with a higher risk of fetal macrosomia (Schaefer-Graf 2003, De Reu 2008, Rosati 2010). In recent years, the fetal interventricular septum thickness, as detected by two-dimensional ultrasound, was shown to be significantly thicker in the presence of gestational diabetes mellitus, independently of maternal glycemic control, when compared to pregnancies with no gestational diabetes mellitus (Ren 2011, Garg 2014).
Current guidelines focus on normalisation of maternal blood glucose concentration. Thus far no study has addressed whether measurement of the fetal interventricular septum thickness can predict adverse pregnancy outcome in euglycemic women with gestational diabetes mellitus.
Detailed description
Rational for the study If fetal interventricular septum hypertrophy in pregnancies with gestational diabetes mellitus appears prior to either fetal abdominal circumference measurement > 90th percentile or the abnormal maternal glucose levels, then future management of women with gestational diabetes mellitus might be targeted earlier at these pregnancies to ensure a more favorable outcome.
Objective To determine the thickness of fetal interventricular septum in women with and without gestational diabetes mellitus and correlates it with perinatal outcome.
Methods Study design This is a prospective study at Rambam Health Care Campus. Inclusion / Exclusion criteria
- Inclusion Study group - women between 24 - 34 weeks' gestation who were diagnosed with gestational diabetes mellitus or known with type I or type II diabetes mellitus. Control group - women between 24 - 34 weeks' gestation who do not have diabetes.
- Exclusion (that might affect directly or indirectly the fetal cardiac function) - women who did not complete a glucose challenge test, smoking, underlying cardiac or respiratory illness, fetal growth restriction, medicated hypertension disorder of pregnancy, multiple pregnancy, use of steroids for lung maturation in the current pregnancy and known major congenital anomalies.
Study population Women who meet the above inclusion criteria will be asked to participate in the study, and will be asked to provide a written informed consent. Both groups, the study and control group, will be recruited when attending their routine prenatal care in the prenatal clinics at Rambam Health Care Campus. Eligible woman will undergo ultrasound examination as they would normally do in each visit. This study, under no circumstances, will alter the participants routine care.
Data Collection
- Maternal and fetal characteristics Data related to the fetomaternal antenatal, intrapartum and postpartum course will be recorded prospectively (Appendix 1).
- Ultrasound assessment Basic transabdominal two-dimensional ultrasound examination using B-mode (either Samsung or Voluson E8), will be carried out first to assess fetal growth and well-being. This is to be continued with a more detailed ultrasound, with a specific focus on the fetal interventricular septum. The entire length of the study, dependent on fetal lie, is expected to take around 15 min. The results of the assessment of fetal growth and well-being will be provided to the patient.
The measurement of the fetal interventricular septum will be as follow (Figure 1 below); maternal suspended respiration, without fetal movement or breathing, level of the 4-chamber view with adequate magnification of the fetal heart (50% of the screen), midpoint of interventricular septum with cine loop to end-diastolic (maximum ventricular filling), and average of 3 measurements (Ren 2011, Garg 2014).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetes group | Active comparator | Diagnostic Test: Fetal interventricular septum thicknessWomen with gestational or pre-gestational diabetes mellitus. |
| Control group | Active comparator | Diagnostic Test: Fetal interventricular septum thicknessWomen without gestational or pre-gestational diabetes mellitus. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Study group - women between 24 - 34 weeks' gestation who were diagnosed with gestational diabetes mellitus or known with type I or type II diabetes mellitus.
- Control group - women between 24 - 34 weeks' gestation who do not have diabetes.
Key exclusion criteria (1 listed)
- women who did not complete a glucose challenge test, smoking, underlying cardiac or respiratory illness, fetal growth restriction, medicated hypertension disorder of pregnancy, multiple pregnancy, use of steroids for lung maturation in the current pregnancy and known major congenital anomalies.
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 |
|---|---|---|
| Fetal interventricular septum thicknessTwo-dimensional ultrasound fetal cardiac imaging test | Diagnostic test | Control group, Diabetes group |
Primary outcome
Fetal interventricular septum thickness
Time frame: Between 24-34 weeks of gestation.
Differences in fetal interventricular septum thickness in both women with gestational or pre-gestational diabetes mellitus and women without gestational or pre-gestational diabetes mellitus.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
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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.
Yaniv Zipori, MD principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fetal interventricular septum thickness in people with Gestational Diabetes, run by Rambam Health Care Campus at 1 site in Israel.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 31 Aug 2018. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yaniv Zipori, MD (0587966963, y_zipori@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fetal interventricular septum thickness (time frame: Between 24-34 weeks of gestation.). 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 31 Aug 2018.