An Attempt of Bridging the Gaps Between Obstetricians and Neonatologists in Congenital Heart Disease Detection and Management at Assiut University Hospitals
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 115
- 主要终点
- Agreement between prenatal and postnatal CHD diagnosis
研究概览
简要总结
This prospective observational study aims to evaluate the agreement between prenatal fetal echocardiographic diagnoses and postnatal diagnoses of congenital heart disease, and to assess the impact of prenatal diagnosis status on neonatal clinical outcomes at Assiut University Hospitals.
详细描述
Congenital heart disease (CHD) is the most common congenital organ system anomaly. Effective perinatal management requires coordinated care between obstetricians and neonatologists. This prospective observational study will include pregnant women referred for fetal echocardiography due to suspected or confirmed CHD, as well as neonates with prenatally or postnatally confirmed cardiac diagnoses.
The study will compare prenatal and postnatal diagnoses, assess neonatal outcomes including mortality and need for emergency intervention, and evaluate communication pathways between obstetric and neonatal teams regarding fetal cardiac findings.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(Postnatal arm)::
- •- Term neonates with confirmed critical CHD
- •Neonates with prenatal CHD diagnosis or postnatal first-time diagnosis
- •Parental written informed consent
- •Inclusion Criteria (Prenatal arm):
- •Singleton pregnancies referred for fetal echocardiography between 18 and 36+6 weeks
- •Suspected cardiac abnormalities on routine obstetric scan
- •Written informed consent
排除标准
- •- Multiple gestations
- •Fetuses with growth restriction (EFW or AC below 3rd percentile)
- •Premature infants (<37 weeks)
- •Neonates with stable CHD not requiring intervention
- •Incomplete records or loss to follow-up
研究组 & 干预措施
Neonates with prenatally diagnosed CHD managed with structured perinatal care plan
Neonates with prenatally diagnosed CHD managed with structured perinatal care plan
Neonates with CHD first diagnosed postnatally
Neonates with CHD first diagnosed postnatally
Neonates with CHD transferred from external centers after birth
Neonates with CHD transferred from external centers after birth
结局指标
主要结局
Agreement between prenatal and postnatal CHD diagnosis
时间窗: Up to 30 days
Proportion of cases with complete agreement between prenatal fetal echocardiographic diagnosis and postnatal confirmed diagnosis of congenital heart disease.
次要结局
- Neonatal all-cause mortality(Up to 30 days)
- Rate of unplanned emergency cardiac intervention(Up to 30 days)
- Duration of NICU stay(Up to 30 days)
- Need for emergency delivery room intervention(Up to 30 days)
- Need for emergency delivery room intervention(Baseline)
研究者
Amany Abd El-Bary Kamel
Resident Physician Department of Pediatrics
Assiut University