PregnancyNCT01845324
Fetal Heart Interventricular Septum in Fetuses of Diabetic Mothers
An observational study of Pregnancy and Diabetes Mellitus, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
The investigators asume that the measurement of the fetal heart interventricular septum can serve as a good tool to predict glucose control in pregnant patients with diabetes mellitus. 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
- Pregnancy, Diabetes Mellitus
- How many people
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- May 2013to Jun 2014
- Phase
- Observational
- 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
Study population: All consequtive pregnant women with Diabetes Mellitus - Gestational and non Gestational
Who may be able to join
- All consequtive pregnant women
- with Diabetes Mellitus - Gestational and non Gestational
Who cannot join
- .No willing to participate.
- Suspected Heart anomaly
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hillel Yaffe Medical Center
Hadera, 38100
Alon Shrim, MD, +972-4-6188224, alon.shrim@gmail.com
About this study
Official title: Relation Between Fetal Heart Interventricular Septum Size and Gestational Diabetes Mellitus Control. a Prospective Trial
The investigators asume that the measurement of the fetal heart interventricular septum can serve as a good tool to predict glucose control in pregnant patients with diabetes mellitus. The investigators will measure the septum width in patients with Diabetes and will correlate to standard measurements of the glucuse levels.
Read the detailed description
In this study the investigators will follow patients with Diabetes Mellitus - mainly gestational. the investigators will measure the width of the interventricular septum and correlate with conventional measures of blood glucose measurements in this population.
The investigators will try to assess whether measurement of the septum can be an earlier and better predictor of glucose control in this population.
- Conditions
- Pregnancy, Diabetes Mellitus
- Keywords
- Pregnancy, Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Diabetes Mellitus in pregnancy | Our cohort will include all consequtive women with Diabetes Mellitus atending our clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
width of fetal interventricula heart septum
The investigator will assess the width of the fetal interventricular septum in patients with diabetes.
Measured: 2 years
Secondary outcomes (1)
glucose control in patients with normal and abnormal interventricular septal width
The investigators will try to show that small interventricular septal width glucose correlates with good glucose control
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study startMay 2013
- Primary completionMay 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Alon Shrim, MD, Principal investigator, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01845324
- Sponsor's protocol ID
- 0011-13
- Status last verified
- Apr 2013
- First submitted
- 9 Apr 2013
- Last updated
- 3 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relation Between Fetal Heart Interventricular Septum Size and Gestational Diabetes Mellitus Control. a Prospective Trial
- ClinicalTrials.gov ID
- NCT01845324
- Acronym / sponsor ID
- 0011-13
- Conditions
- Pregnancy, Diabetes Mellitus
- Keywords
- Pregnancy, Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- May 2013
- Primary completion
- May 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 3 May 2013 (estimated)
- 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.
The investigators asume that the measurement of the fetal heart interventricular septum can serve as a good tool to predict glucose control in pregnant patients with diabetes mellitus. The investigators will measure the septum width in patients with Diabetes and will correlate to standard measurements of the glucuse levels.
Detailed description
In this study the investigators will follow patients with Diabetes Mellitus - mainly gestational. the investigators will measure the width of the interventricular septum and correlate with conventional measures of blood glucose measurements in this population.
The investigators will try to assess whether measurement of the septum can be an earlier and better predictor of glucose control in this population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetes Mellitus in pregnancy | – | –Our cohort will include all consequtive women with Diabetes Mellitus atending our clinic |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- All consequtive pregnant women with Diabetes Mellitus - Gestational and non Gestational
Key inclusion criteria (2 listed)
- All consequtive pregnant women
- with Diabetes Mellitus - Gestational and non Gestational
Key exclusion criteria (2 listed)
- .No willing to participate.
- Suspected Heart anomaly
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
width of fetal interventricula heart septum
Time frame: 2 years
The investigator will assess the width of the fetal interventricular septum in patients with diabetes.
1 secondary outcome
glucose control in patients with normal and abnormal interventricular septal width
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2013.
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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.
Alon Shrim, MD principal investigator
Hillel Yaffe Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy and Diabetes Mellitus, run by Hillel Yaffe Medical Center 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 2 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 3 May 2013. 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 Alon Shrim, MD (+972-4-6188224, alon.shrim@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
width of fetal interventricula heart septum (time frame: 2 years). 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 3 May 2013.