Fetal Cardiac Remodeling in Singleton Pregnancies Conceived by Assisted Reproductive Technology (Biopsied and Non-Biopsied ICSI) Versus Those Normally Conceived
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- 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)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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)
时间窗: 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)
次要结局
- 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(8 weeks)