Program of Research for the Optimization of a Supervised Patient Pathway for Expectant According to Risk in Obstetrics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,532
- 试验地点
- 4
- 主要终点
- Rate of patients'pathway approved as compliant in the intervention group compared to the control group.
研究概览
简要总结
This French multicentre open-label randomized trial will test the hypothesis that a coordinated health circuit based on obstetric risks, backed up by an electronic patient care reporting information system will optimize the continuum of pregnancy care monitoring. The electronic patient care reporting information system will be shared between patients, private practice physicians/midwifes, hospital physicians/midwifes and supervised by a coordinating midwife.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
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
- •patients over the age of majority,
- •enrolled in one of the two maternity hospitals in the study before 12 weeks of amenorrhea (SA) and 6 days (j) of age,
- •affiliated to the National Health Insurance Fund of the country within the regional level health insurance
- •have an internet access
排除标准
- •illiterate patients,
- •non-French speakers,
- •under the age of majority,
- •refusing to participate,
- •without internet access,
- •followed by one of these maternity wards but delivering else where,
- •whose pregnancy ended in a miscarriage early or late (before 21 weeks of amenorrhea (SA) and 6 days (J) over).
研究组 & 干预措施
PROSPERO group (intervention group)
干预措施: PROSPERO (Behavioral)
control group
干预措施: control (Other)
结局指标
主要结局
Rate of patients'pathway approved as compliant in the intervention group compared to the control group.
时间窗: at the end of pregnancy
Compliant patient pathways are those for which all actions (medical visits, examinations, …) recommended during pregnancy, according to the specific risk factors of each patient, will have been made.
Rate of patients'pathway approved as compliant in the intervention group compared to the control group.
时间窗: at the end of pregnancy
Compliant patient pathways are those for which all actions (medical visits, examinations, …) recommended during pregnancy, according to the specific risk factors of each patient, will have been made.
次要结局
- rate of severe maternal morbidity and mortality as defined by the EPIdémiologie de la MOrbidité Maternelle Sévère (EPINOMS) project(From 22 completed weeks (154 days) of gestation to seven completed days after birth)
- types of delivery(within one week from the date of delivery)
- rate of perinatal morbidity-mortality as defined by the Organization, Practices Evaluation in perinatal Network(From 22 completed weeks (154 days) of gestation to seven completed days after birth)
- patients' satisfaction : Qualitative evaluation by interview(within one week from the date of delivery)
- patients' satisfaction : Quantitative evaluation by the hospital anxiety and depression scale(within one week from the date of delivery)
- completeness of all hospital medical records(the end of pregnancy (the date of delivery))
- health care costs(one week from the date of delivery)