Heart Disease Structural Disorder Abscess of Cardiac SeptumNCT03043937
Cardiac Diseases With Pregnancy in Benisuef Localities
An observational study of Heart Disease Structural Disorder Abscess of Cardiac Septum, run by Beni-Suef University at 1 site in Egypt.
Trial summary
The aim of this work is to demonstrate the variation of cardiac diseases among pregnant ladies in our localities, detect maternal \& fetal complications and to predict the risk factors for poor maternal, fetal \& neonatal outcomes 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
- Heart Disease Structural Disorder Abscess of Cardiac Septum
- What is being tested?
- registry
- How many people
- 400 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2015to Dec 2016
- How long will I take part?
- 2 Years
- 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: A prospective analytical study is managed to be commenced in Beni-Suef governorate as cooperation between Department of Cardiology and Department of Obstetrics and Gynaecology Beni-Suef University during the period between Jan/2015 and Dec/2016 among women with cardiac diseases during pregnancy regardless gestational age at presentation and up till 6 weeks postpartum in comparison to women free from any cardiac diseases.
Who may be able to join
- All pregnant ladies with Cardiac diseases, valvular heart disease, congenital heart disease, ischemic heart disease, cardiomyopathy, arrhythmias , big and pulmonary hypertension, presenting with pregnancy regardless age, any concomitant diseases and type of heart disease will be enrolled.
- A similar number of pregnant females free from previous mentioned cardiac diseases will be studied as controls.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this work is to demonstrate the variation of cardiac diseases among pregnant ladies in our localities, detect maternal \& fetal complications and to predict the risk factors for poor maternal, fetal \& neonatal outcomes
- Being tested
- registry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
registryOther
| Study group | Role | What they receive |
|---|---|---|
| cardiac patients WHO class 1,2 | Not described Receives: Other: registry | |
| cardiac patients WHO class 3,4 | Not described Receives: Other: registry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fetomaternal and neonatal outcome
Number of Participants With abortion,preterm labour,Intrauterine fetal death,Postterm fetus, intrauterine growth restriction,Fetuses with Congenital heart diseases,Neonatal admission to Neonatal Intensive care unit,neonatal death,Perineal,vaginal,broad ligament haematoma, Internal Hemorrhage due to anticoagulant drugs,malfunctioning valve,heart failure ,Thromboembolic complications, perinatal maternal death.
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 posted6 Feb 2017 (estimated)
- Study startJan 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Disease Structural Disorder Abscess of Cardiac SeptumStudies of the same condition, open and under way.
- More trials run by Beni-Suef 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
- Other
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Momen Zakaria Mohammed mohammed, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03043937
- Sponsor's protocol ID
- 1200
- Status last verified
- May 2017
- First submitted
- 6 Jan 2017
- Last updated
- 19 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Diseases With Pregnancy in Benisuef Localities
- ClinicalTrials.gov ID
- NCT03043937
- Acronym / sponsor ID
- 1200
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 6 Feb 2017 (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 aim of this work is to demonstrate the variation of cardiac diseases among pregnant ladies in our localities, detect maternal \& fetal complications and to predict the risk factors for poor maternal, fetal \& neonatal outcomes
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cardiac patients WHO class 1,2 | – | Other: registry |
| cardiac patients WHO class 3,4 | – | Other: registry |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- A prospective analytical study is managed to be commenced in Beni-Suef governorate as cooperation between Department of Cardiology and Department of Obstetrics and Gynaecology Beni-Suef University during the period between Jan/2015 and Dec/2016 among women with cardiac diseases during pregnancy regardless gestational age at presentation and up till 6 weeks postpartum in comparison to women free from any cardiac diseases.
Key inclusion criteria (2 listed)
- All pregnant ladies with Cardiac diseases, valvular heart disease, congenital heart disease, ischemic heart disease, cardiomyopathy, arrhythmias , big and pulmonary hypertension, presenting with pregnancy regardless age, any concomitant diseases and type of heart disease will be enrolled.
- A similar number of pregnant females free from previous mentioned cardiac diseases will be studied as controls.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| registry | Other | cardiac patients WHO class 1,2, cardiac patients WHO class 3,4 |
Primary outcome
Fetomaternal and neonatal outcome
Time frame: 2 years
Number of Participants With abortion,preterm labour,Intrauterine fetal death,Postterm fetus, intrauterine growth restriction,Fetuses with Congenital heart diseases,Neonatal admission to Neonatal Intensive care unit,neonatal death,Perineal,vaginal,broad ligament haematoma, Internal Hemorrhage due to anticoagulant drugs,malfunctioning valve,heart failure ,Thromboembolic complications, perinatal maternal death.
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 19 May 2017.
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 Heart Disease Structural Disorder Abscess of Cardiac Septum, run by Beni-Suef 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 2 inclusion and 0 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 19 May 2017. 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?
Fetomaternal and neonatal outcome (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 19 May 2017; AzTrials last refreshed its copy on 7 Nov 2026.