Diagnostic Accuracy of 10-Minute Vs 30-Minute CTG in Intrapartum Fetal Monitoring.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 主要终点
- To compare the diagnostic accuracy (sensitivity, specificity, PPV, NPV) of a 10 minute CTG versus a standard 30-minute CTG in fetal monitoring and well being
研究概览
简要总结
Cardiotocography (CTG) is a cornerstone of intrapartum fetal monitoring but requires a minimum of 30 minutes for a reliable trace, creating a significant bottleneck in high-volume, low-resource settings like Egypt As it is time-consuming and resource intensive. This leads to delays in care and increased workload for healthcare providers. A shortened, yet accurate, CTG protocol could drastically improve workflow and resource allocation without compromising fetal safety.
详细描述
In Egypt, labor wards in tertiary hospitals are often overcrowded with limited CTG machines and midwives. The requirement of a minimum 30-minute CTG trace creates bottlenecks in care and increases staff workload. Previous studies suggest that the first 10 minutes of a CTG may capture the essential features of fetal well-being. If validated, a shortened CTG could improve efficiency in high-volume maternity units without compromising neonatal outcomes. Using umbilical venous pH as the gold standard for fetal acid-base status, this study will directly compare the diagnostic accuracy of a 10-minute versus a 30-minute CTG protocol in low-risk laboring women. The aim is to evaluate whether a 10-minute CTG tracing is non-inferior to the standard 30 minute CTG in fetal assessment and predicting fetal acid-base status (umbilical venous pH) in term, low-risk pregnancies during the active first stage of labor.
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
- •Singleton pregnancy.
- •Gestational age ≥ 37 weeks.
- •Vertex presentation.
- •Active first stage of labor (cervical dilation ≥ 4 cm).
- •Low-risk pregnancy (no hypertension, diabetes, IUGR, or other significant complications).
排除标准
- •• Multiple gestation.
- •Known major fetal anomaly.
- •Non-vertex presentation.
- •Indication for continuous CTG (e.g., meconium-stained liquor, antepartum hemorrhage).
- •Maternal refusal.
结局指标
主要结局
To compare the diagnostic accuracy (sensitivity, specificity, PPV, NPV) of a 10 minute CTG versus a standard 30-minute CTG in fetal monitoring and well being
时间窗: Immediately after birth
Using fetal acidemia defined as (umbilical venous pH \< 7.25) as reference in detecting fetal will being and comparing results with 10-min \& 30-min CTG monitoring to evaluate diagnostic accuracy of both in detecting fetal acidemia.
次要结局
未报告次要终点
研究者
Soliman Mohamed Soliman Alazhary
Dr.Soliman Mohamed Alazhary
Assiut University