Prospective Study of Antenatal Diagnostic Criteria for Digestive Complications of Gastroschisis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 36
- 主要终点
- Evaluation of the collar diameter/abdominal circumference ratio as a predictive factor of complex gastroschisis.
研究概览
简要总结
Gastroschisis is a rare congenital malformation consisting in a right para-umbilical defect of the abdominal wall leading to an evisceration of the abdominal content. About 25% of the cases are associated with intestinal malformation, leading to an increase in peri-natal morbidity and mortality. No prospective study has been able to definitely describe predictive factors for complicated gastroschisis on prenatal ultrasound examinations.
The aim of the current study is to prospectively look for US prenatal features predictive of complicated gastroschisis, on a national multicentric cohort.
Patients will be included during the 22 weeks of amenorrhea (WA) ultrasound examination, and pre- and postnatal clinical data will be recorded up to the 6th months of the child.
Data will then be analysed and compared in the groups of simple or complicated gastroschisis, in order to define pre-natal prognostic factors, to correlate them with specific prognosis, and to might better determine specific strategies for better care of these patients.
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
- •Every volunteer pregnant woman, in whom an antenatal ultrasound diagnosis of gastroschisis has been carried, before the end of 22 weeks of amenorrhea.
排除标准
- •Lack of informed consent or refusal of the person to participate in study
结局指标
主要结局
Evaluation of the collar diameter/abdominal circumference ratio as a predictive factor of complex gastroschisis.
时间窗: 2,5 years
The measures of the collar diameter/abdominal circumference ratio on antenatal ultrasound examination will be evaluated as predictive factor of complex gastroschisis
次要结局
- Composite predictive criterion of complex gastroschisis(2,5 years)
- Composite predictive criterion of complex gastroschisis by MRI(2,5 years)
- Evaluation of antenatal ultrasound in predictive diagnosis of complex gastroschisis(2,5 years)
- Measure the impact of complex gastroschisis on follow-up until 6 months of children(6 months of child's life)
- Research risk factors in the mother(2,5 years)
- Propose a decision algorithm for prenatal management of these patients(2,5 years)