Maternal Diabetes Mellites Effect on FetusNCT02136602
Interventricular Cardiac Septal Thickness in Fetus of Diabetic Mother Correlated to Postnatal Outcome
An observational study of Maternal Diabetes Mellites Effect on Fetus, run by Ain Shams University at 1 site in Egypt.
Trial summary
Good glycemic control is superior to poor glycemic control in reducing risk of interventricular septal thickness among fetuses of diabetic mothers. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Maternal Diabetes Mellites Effect on Fetus
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2012to Apr 2014
- How long will I take part?
- 2 Months
- 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 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: pregnant women with diabetes mellites
Who may be able to join
- above 35 weeks pregnancy
- diabetic mothers
- single intrauterine pregnancy
Who cannot join
- any other medical disorder
Trial locations and contacts
1 site in 1 country.
About this study
Good glycemic control is superior to poor glycemic control in reducing risk of interventricular septal thickness among fetuses of diabetic mothers.
Read the detailed description
Thick Interventricular septum is thought to be related to poor glycemic control during pregnancy, and it causes variable degree of left ventricular outflow obstruction and hypertrophic cardiomyopathy.
Hypertrophic cardiomyopathy requires specific management as digoxin and inotropic agents usually used in heart failure are contraindicated.
So high index of suspicion is required in fetus of diabetic mother having thick Inter ventricular septum.
What is being measured
The primary outcome is the main question the study is designed to answer.
To study interventricular septal thickness in fetus of diabetic mother and correlate it with good glycemic control.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2014 (estimated)
- Study startJan 2012
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal Diabetes Mellites Effect on FetusStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, heba elsyed, Ain Shams University
- Investigators
- Mohammed M Elsafty, obs&gyn lecturer., Study director, Ain Shames university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02136602
- Sponsor's protocol ID
- hct 4321
- Status last verified
- May 2014
- First submitted
- 6 Nov 2013
- Last updated
- 13 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventricular Cardiac Septal Thickness in Fetus of Diabetic Mother Correlated to Postnatal Outcome
- ClinicalTrials.gov ID
- NCT02136602
- Acronym / sponsor ID
- hct 4321
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 13 May 2014 (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.
Good glycemic control is superior to poor glycemic control in reducing risk of interventricular septal thickness among fetuses of diabetic mothers.
Detailed description
Thick Interventricular septum is thought to be related to poor glycemic control during pregnancy, and it causes variable degree of left ventricular outflow obstruction and hypertrophic cardiomyopathy.
Hypertrophic cardiomyopathy requires specific management as digoxin and inotropic agents usually used in heart failure are contraindicated.
So high index of suspicion is required in fetus of diabetic mother having thick Inter ventricular septum.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Months
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- pregnant women with diabetes mellites
Key inclusion criteria (3 listed)
- above 35 weeks pregnancy
- diabetic mothers
- single intrauterine pregnancy
Key exclusion criteria (1 listed)
- any other medical disorder
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
To study interventricular septal thickness in fetus of diabetic mother and correlate it with good glycemic control.
Time frame: 6 month
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 13 May 2014.
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.
Mohammed M Elsafty, obs&gyn lecturer. study director
Ain Shames university
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 Maternal Diabetes Mellites Effect on Fetus, run by Ain Shams University at 1 site in Egypt.
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 3 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: finished, as of the sponsor's last update on 13 May 2014. 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 Egypt. 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?
To study interventricular septal thickness in fetus of diabetic mother and correlate it with good glycemic control. (time frame: 6 month). 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 13 May 2014.