Impact of Conditional Financial Support on Pregnancy Outcomes in Pregnant Women With Low Incomes: Pragmatic Randomized Cluster Trial, With Parallel Arms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,787
- 试验地点
- 18
- 主要终点
- Occurence of complication(s) of pregnancy, wether maternal, fetal or neonatal
研究概览
简要总结
This study aims to evaluate the impact of financial support on improving the management of prenatal care in pregnant women with low incomes. The judgment criterion is clinically pertinent: complications of pregnancy. This study also aims to evaluate attitudes to this approach through a qualitative survey.
It is planned to include 4000 women distributed into two arms of 2000 each. One group will receive financial support (prepaid payment card credited for each consultation attended according to the scheduled follow-up as recommended by the Haute Autorité de Santé); the other group will not. The management of the pregnancy for both groups will not be modified.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Pregnant women
- •Age > 18 years
- •1st consultation before the 26th week of amenorrhea
- •Recipient of free health care (Couverture Maladie Universelle, Couverture Maladie Universelle-Complémentaire)
- •Who have provided written informed consent to take part in the study
排除标准
- •Persons without national health insurance cover
- •Persons unable to understand the information on the study, despite the help of a translator or a person of trust if necessary
- •Persons under guardianship
结局指标
主要结局
Occurence of complication(s) of pregnancy, wether maternal, fetal or neonatal
时间窗: Participants will be followed for the duration of hospital stay and for a maximum of one month after the term date.
次要结局
- Neonatal morbidity, mortality and rate of transfer of the newborn to a neonatal care unit.(Participants will be followed for the duration of hospital stay and for a maximum of one month after the term date.)