Fetal Cardiac Disorder Clinical Trial
Official title:
Fetal Cardiac Remodeling in Singleton Pregnancies Conceived by Assisted Reproductive Technology (Biopsied and Non-Biopsied ICSI) Versus Those Normally Conceived
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).
Status | Recruiting |
Enrollment | 111 |
Est. completion date | December 30, 2023 |
Est. primary completion date | November 30, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 49 Years |
Eligibility | Inclusion Criteria: 1. Women aged >18 years 2. Singleton pregnancy 3. Women who are willing and able to attend serial ultrasonographic examinations during the whole pregnancy 4. Women willing to sign an informed consent Exclusion Criteria: 1. Multiple pregnancies; more than one fetus 2. 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 3. Diagnosis of fetal malformations; fetus with a structural or chromosomal anomaly 4. 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. 5. Smokers or drug/alcohol women 6. Inability to understand and provide written informed consent |
Country | Name | City | State |
---|---|---|---|
Egypt | National Research center | Cairo |
Lead Sponsor | Collaborator |
---|---|
Wael Elbanna Clinic | National Research Centre, Egypt |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) |
2 weeks | |
Secondary | 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* |
8 weeks |
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