Cardiology in Fetus of Diabetic MotherNCT01599026
Cardiac Septal Hypertrophy in the Fetus of Diabetic Mother and Its Effect on Postnatal Cardiac Function
An observational study of Cardiology in Fetus of Diabetic Mother, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial summary
Good glycemic control is superior to poor glycemic control in reducing risk of interventricular septum 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
- Cardiology in Fetus of Diabetic Mother
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2012to Mar 2013
- 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: diabetic pregnant ladies gestational age more than 35 weeks
Who may be able to join
- singleton pregnancy
- gestational age 36 weeks
Who cannot join
- congenital anomalies
- obstetric complications
- medical disorders other than diabetes
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 septum thickness among fetuses of diabetic mothers
Read the detailed description
Good glycemic control is superior to poor glycemic control in reducing risk of interventricular septum thickness among fetuses of diabetic mothers specially during third trimester of pregnancy
- Conditions
- Cardiology in Fetus of Diabetic Mother
- Keywords
- cardiology, fetus of diabetic mother
What is being measured
The primary outcome is the main question the study is designed to answer.
To study interventricular septum thickness in fetus of diabetic mother and correlate it with good glycemic control.
To study interventricular septum thickness in fetus of diabetic mother and correlate it with good glycemic control during third trimester of pregnancy.
Measured: one year
Secondary outcomes (1)
cardiac function in infant of diabetic mother
To correlate postnatal cardiac function to interventricular septum thickness to reach cut of value of septum thickness for prenatal prediction of symptomatic cardiomyopathy in infant of diabetic mother.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2012 (estimated)
- Study startApr 2012
- Primary completionFeb 2013 (estimated)
- Study completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiology in Fetus of Diabetic MotherStudies 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
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, heba mohamed, Ain Shams Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01599026
- Sponsor's protocol ID
- dhvf 7531
- Status last verified
- May 2012
- First submitted
- 14 May 2012
- Last updated
- 15 May 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Septal Hypertrophy in the Fetus of Diabetic Mother and Its Effect on Postnatal Cardiac Function
- ClinicalTrials.gov ID
- NCT01599026
- Acronym / sponsor ID
- dhvf 7531
- Conditions
- Cardiology in Fetus of Diabetic Mother
- Keywords
- cardiology, fetus of diabetic mother
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Feb 2013 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 15 May 2012 (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 septum thickness among fetuses of diabetic mothers
Detailed description
Good glycemic control is superior to poor glycemic control in reducing risk of interventricular septum thickness among fetuses of diabetic mothers specially during third trimester of pregnancy
Study design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- diabetic pregnant ladies gestational age more than 35 weeks
Key inclusion criteria (2 listed)
- singleton pregnancy
- gestational age 36 weeks
Key exclusion criteria (3 listed)
- congenital anomalies
- obstetric complications
- medical disorders other than diabetes
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 septum thickness in fetus of diabetic mother and correlate it with good glycemic control.
Time frame: one year
To study interventricular septum thickness in fetus of diabetic mother and correlate it with good glycemic control during third trimester of pregnancy.
1 secondary outcome
cardiac function in infant of diabetic mother
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2012.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cardiology in Fetus of Diabetic Mother, run by Ain Shams Maternity Hospital 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 2 inclusion and 3 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 15 May 2012. 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?
Results are not available in the source record.
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 septum thickness in fetus of diabetic mother and correlate it with good glycemic control. (time frame: one year). 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 15 May 2012.