Prospective Study of Fetal Cardiac Anomalies Detected During Antenatal Fetal Anomaly Scanning at the Fetomaternal Unit, Women's Health Hospital, Assiut University: Detection and Pregnancy Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 主要终点
- Frequency of Fetal Cardiac Anomalies Detected at Anomaly Scan
研究概览
简要总结
Congenital heart defects are among the most common congenital anomalies and cause significant perinatal morbidity and mortality. Prenatal detection allows counseling, multidisciplinary planning and optimization of delivery. This prospective observational cohort study will screen all pregnant women attending the Fetomaternal Unit, Women's Health Hospital, Assiut University for anomaly scan at 18+0 to 22+6 weeks gestation over 12 months. All cases with suspected or detected fetal cardiac anomalies will be consecutively recruited and followed antenatally until delivery and postnatally when possible. Primary outcome is frequency of fetal cardiac anomalies among screened fetuses. Secondary outcomes include frequency of each type of anomaly, NICU admission, need for neonatal cardiac surgery or intervention, and neonatal death. Data will be analyzed using SPSS with descriptive statistics and chi-square or Fisher exact test and t-test or Mann-Whitney as appropriate. P less than 0.05 is considered significant.
详细描述
All eligible pregnant women attending the Fetomaternal Unit for second-trimester anomaly scanning will undergo standardized fetal anatomical and cardiac assessment including situs, cardiac position and axis, four-chamber view, outflow tracts, three-vessel view, three-vessel-trachea view when possible, and cardiac rhythm. Cases with suspected cardiac anomalies will undergo detailed documentation and fetal echocardiography when clinically indicated according to routine practice. They will be counseled and followed with assessment of fetal growth, cardiac function, hydrops and progression. Pregnancy outcomes including gestational age at delivery, mode of delivery, birth weight, Apgar scores, NICU admission, neonatal cardiac intervention and survival will be collected. Postnatal echocardiography will be recorded when available to confirm antenatal diagnosis. The study involves no experimental intervention.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Gestational age between 18+0 and 22+6 weeks at the time of the anomaly scan
- •Singleton or multiple pregnancy
- •Written informed consent
排除标准
- •Incomplete essential ultrasound or clinical information
- •Cases in which the initial cardiac assessment cannot be completed
研究组 & 干预措施
Single cohort: Pregnant women undergoing anomaly scan
Pregnant women undergoing second-trimester anomaly scanning in whom fetal cardiac anomalies are detected or suspected and will be followed for pregnancy and neonatal outcomes.
结局指标
主要结局
Frequency of Fetal Cardiac Anomalies Detected at Anomaly Scan
时间窗: At time of anomaly scan, 18+0 to 22+6 weeks gestation
Proportion of fetuses with cardiac anomalies among all fetuses undergoing anomaly screening at 18+0 to 22+6 weeks. Includes any structural abnormality of heart and great vessels
次要结局
- Frequency of Specific Types of Cardiac Anomalies(At diagnosis, 18+0 to 22+6 weeks and confirmed by fetal echocardiography)
- Frequency of NICU Admission(From birth to discharge, up to 28 days after birth)
- Frequency of Neonatal Cardiac Surgery(From birth to 28 days after birth)
- Frequency of Neonatal Death(From birth to 28 days after birth)
研究者
Mina Nasser Rasmy
Resident Physician
Assiut University