Fetal Cardiac DisorderNCT05172336
Fetal Cardiac Remodeling in Singleton Pregnancies Conceived by Assisted Reproductive Technology (Biopsied and Non-Biopsied ICSI) Versus Those Normally Conceived
An observational study of Fetal Cardiac Disorder, run by Wael Elbanna Clinic at 1 site in Egypt.
Trial summary
The study aims to assess the presence of fetal cardiac remodeling and dysfunction in singleton pregnancies conceived by assisted reproductive technology (Biopsied and Non-Biopsied ICSI) as compared with those conceived spontaneously (SC). Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Cardiac Disorder
- How many people
- 111 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Aug 2021to 30 Dec 2023
- 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 49 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Singleton pregnant women conceived by: * Assisted reproductive technology (Biopsied ICSI) * Assisted reproductive technology (Non-Biopsied ICSI) * Spontaneous conception (SC)
Who may be able to join
- Women aged >18 years
- Singleton pregnancy
- Women who are willing and able to attend serial ultrasonographic examinations during the whole pregnancy
- Women willing to sign an informed consent
Who cannot join
- Multiple pregnancies; more than one fetus
- Any maternal medical disease, including asthma, chronic hypertension, diabetes mellitus, heart disease, extracardiac anomalies, human immunodeficiency virus or hepatitis infection, immunological disorders, lupus, and thyroid disease
- Diagnosis of fetal malformations; fetus with a structural or chromosomal anomaly
- Fetus with Small-for-Gestational-Age (SGA) or intrauterine Growth Restriction (IUGR) (a fetal weight that is below the 10th percentile for gestational age) as determined through an ultrasound.
- Smokers or drug/alcohol women
- Inability to understand and provide written informed consent
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
National Research center
Cairo
Wael Elbanna, consultant, 01227760402, waelelbanna@drwaelelbanna.com
Manal Elhinnawi, specialist, 01007970546, manalelhinnawi@hotmail.com
About this study
The study aims to assess the presence of fetal cardiac remodeling and dysfunction in singleton pregnancies conceived by assisted reproductive technology (Biopsied and Non-Biopsied ICSI) as compared with those conceived spontaneously (SC).
Read the detailed description
For gynecologists, reaching a conclusion about fetal cardiac remodeling and dysfunction in singleton pregnancies conceived by assisted reproductive technology (Biopsied and Non-Biopsied ICSI) or conceived spontaneously (SC) that would influence the clinical decision and best practice. Besides enriching the clinical evidence in fetal cardiac remodeling and dysfunction.
For society, the conclusion and recommendation shall maximize the benefits and managing the benefits of the technique used. Moreover, providing more information for fetal cardiac remodeling and dysfunction.
- Conditions
- Fetal Cardiac Disorder
- Keywords
- fetal echocardiography
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 |
|---|---|---|
| Assisted reproductive technology (Biopsied ICSI) | the study materials that will be used will include fetal ultrasound (fetal echocardiography) at 29 weeks ± 1week gestation. | |
| Assisted reproductive technology (Non-Biopsied ICSI) | the study materials that will be used will include fetal ultrasound (fetal echocardiography) at 29 weeks ± 1week gestation. | |
| Spontaneous conception (SC) | the study materials that will be used will include fetal ultrasound (fetal echocardiography) at 29 weeks ± 1week gestation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the presence of fetal cardiac remodeling and dysfunction in singleton pregnancies conceived by assisted reproductive technology (Biopsied and Non-Biopsied ICSI) as compared with those conceived spontaneously (SC)
Recording the fetal echocardiography data including:
- Standard fetoplacental data
- Estimated fetal weight (g)
- Estimated fetal weight (centile)
- Uterine artery mean PI
- Umbilical artery PI
- Middle cerebral artery PI
- Cerebroplacental ratio
- Ductus venosus PI
- Aortic isthmus PI
- Cardiac morphometric data
- Cardiothoracic ratio
- Left atrial/heart ratio
- Right atrial/heart ratio
- Left ventricular sphericity index
- Right ventricular sphericity index
- Left ventricular free wall thickness (mm)
- Septal wall thickness (mm)
- Right ventricular free wall thickness (mm)
- Myocardial Performance Index (MPI)
- Systolic function data
- Left ejection fraction (%)
- Right ejection fraction (%)
- MAPSE (mm)
- TAPSE (mm)
- Diastolic function data
- Mitral E/A ratio
- Tricuspid E/A ratio
- Left isovolumic relaxation time (ms)
- Gestational age at ultrasound examination (weeks)
Measured: 2 weeks
Secondary outcomes (1)
To describe the baseline and perinatal characteristics in singleton fetuses conceived by assisted reproductive technology (Biopsied and Non-Biopsied ICSI) as compared with those conceived spontaneously (SC
- Maternal characteristics
- Age (years)
- BMI (kg/m2)
- Primiparous
- Pregnancy complications
- Pre-eclampsia
- Corticoid exposure
- Gestational diabetes
- Delivery data
- GA (weeks)
- Cesarean section
- Gender
- Birth weight (g)
- Birth weight centile
- SGA (small-for gestational age)
- Neonatal outcome data
- Admission to NICU
- Major neonatal morbidity*
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start28 Aug 2021
- Primary completion30 Nov 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Cardiac DisorderStudies 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
- 111 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wael Elbanna Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Centre, Egypt
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05172336
- Sponsor's protocol ID
- Elbanna_004
- Status last verified
- Aug 2023
- First submitted
- 8 Dec 2021
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal Cardiac Remodeling in Singleton Pregnancies Conceived by Assisted Reproductive Technology (Biopsied and Non-Biopsied ICSI) Versus Those Normally Conceived
- ClinicalTrials.gov ID
- NCT05172336
- Acronym / sponsor ID
- Elbanna_004
- Conditions
- Fetal Cardiac Disorder
- Keywords
- fetal echocardiography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 111 participants (estimated)
- Lead sponsor
- Wael Elbanna ClinicUniversity, hospital or other
- Collaborators
- National Research Centre, Egypt
- Study start
- 28 Aug 2021 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 29 Dec 2021 (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.
The study aims to assess the presence of fetal cardiac remodeling and dysfunction in singleton pregnancies conceived by assisted reproductive technology (Biopsied and Non-Biopsied ICSI) as compared with those conceived spontaneously (SC).
Detailed description
For gynecologists, reaching a conclusion about fetal cardiac remodeling and dysfunction in singleton pregnancies conceived by assisted reproductive technology (Biopsied and Non-Biopsied ICSI) or conceived spontaneously (SC) that would influence the clinical decision and best practice. Besides enriching the clinical evidence in fetal cardiac remodeling and dysfunction.
For society, the conclusion and recommendation shall maximize the benefits and managing the benefits of the technique used. Moreover, providing more information for fetal cardiac remodeling and dysfunction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Assisted reproductive technology (Biopsied ICSI) | – | –the study materials that will be used will include fetal ultrasound (fetal echocardiography) at 29 weeks ± 1week gestation. |
| Assisted reproductive technology (Non-Biopsied ICSI) | – | –the study materials that will be used will include fetal ultrasound (fetal echocardiography) at 29 weeks ± 1week gestation. |
| Spontaneous conception (SC) | – | –the study materials that will be used will include fetal ultrasound (fetal echocardiography) at 29 weeks ± 1week gestation. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Singleton pregnant women conceived by: * Assisted reproductive technology (Biopsied ICSI) * Assisted reproductive technology (Non-Biopsied ICSI) * Spontaneous conception (SC)
Key inclusion criteria (4 listed)
- Women aged >18 years
- Singleton pregnancy
- Women who are willing and able to attend serial ultrasonographic examinations during the whole pregnancy
- Women willing to sign an informed consent
Key exclusion criteria (6 listed)
- Multiple pregnancies; more than one fetus
- Any maternal medical disease, including asthma, chronic hypertension, diabetes mellitus, heart disease, extracardiac anomalies, human immunodeficiency virus or hepatitis infection, immunological disorders, lupus, and thyroid disease
- Diagnosis of fetal malformations; fetus with a structural or chromosomal anomaly
- Fetus with Small-for-Gestational-Age (SGA) or intrauterine Growth Restriction (IUGR) (a fetal weight that is below the 10th percentile for gestational age) as determined through an ultrasound.
- Smokers or drug/alcohol women
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 assess the presence of fetal cardiac remodeling and dysfunction in singleton pregnancies conceived by assisted reproductive technology (Biopsied and Non-Biopsied ICSI) as compared with those conceived spontaneously (SC)
Time frame: 2 weeks
Recording the fetal echocardiography data including: 1. Standard fetoplacental data * Estimated fetal weight (g) * Estimated fetal weight (centile) * Uterine artery mean PI * Umbilical artery PI * Middle cerebral artery PI * Cerebroplacental ratio * Ductus venosus PI * Aortic isthmus PI 2. Cardiac morphometric data * Cardiothoracic ratio * Left atrial/heart ratio * Right atrial/heart ratio * Left ventricular sphericity index * Right ventricular sphericity index * Left ventricular free wall thickness (mm) * Septal wall thickness (mm) * Right ventricular free wall thickness (mm) * Myocardial Performance Index (MPI) 3. Systolic function data * Left ejection fraction (%) * Right ejection fraction (%) * MAPSE (mm) * TAPSE (mm) 4. Diastolic function data * Mitral E/A ratio * Tricuspid E/A ratio * Left isovolumic relaxation time (ms) 5. Gestational age at ultrasound examination (weeks)
1 secondary outcome
To describe the baseline and perinatal characteristics in singleton fetuses conceived by assisted reproductive technology (Biopsied and Non-Biopsied ICSI) as compared with those conceived spontaneously (SC
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
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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.
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 Fetal Cardiac Disorder, run by Wael Elbanna Clinic 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 4 inclusion and 6 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 10 Oct 2023. 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?
Contact Wael El Banna, Consultant (01227760402, waelelbanna@drwaelelbanna.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the presence of fetal cardiac remodeling and dysfunction in singleton pregnancies conceived by assisted reproductive technology (Biopsied and Non-Biopsied ICSI) as compared with those conceived spontaneously (SC) (time frame: 2 weeks). 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 10 Oct 2023.