A Multicenter, Observational Study to Identify Factors That Influence Access of Pregnant Women and Their Infants to Their Local Healthcare Systems
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,243
- 试验地点
- 10
- 主要终点
- Percentage of Subjects Delivering at a Non-study Site.
研究概览
简要总结
This study collected information regarding the factors that might influence access of pregnant women to the local healthcare system. The main visits of the study screened & enrollment, delivery and 90 day infant follow-up. Data were collected mainly from questionnaires administered to pregnant women at these visits. The questionnaires contained the following standard questions which were asked at each visit, in addition to some visit-specific questions related to delivery and health status of infants up to 90 days of age. The standard questions related to the following aspects:
- Logistics of transportation to the study site (type, time it takes, cost incurred)
- Accessibility to a telephone/cell phone
- Provisions of alternative child care during site visits if there are other children under the subject's care
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women with gestational age of greater than or equal to 24 weeks at the time of enrollment
- •Subject / subject's parents or a legal representative who has given written consent after the nature of the study has been explained according to local regulatory requirements
- •Pregnant women of gestational age between 28 weeks and 34 weeks 6/7 days
排除标准
- 未提供
结局指标
主要结局
Percentage of Subjects Delivering at a Non-study Site.
时间窗: Baseline until average of 24 weeks
The percentage of subjects who delivered at a non-study site relative to the number of enrolled subjects was calculated.
Percentage of Subjects Delivering at a Study Site.
时间窗: Baseline until average of 24 weeks
The percentage of subjects who delivered at the study site relative to the number of enrolled subjects was calculated
次要结局
- Number of Infants Brought to Study Site During Infant Follow up (90 Days Post-delivery)(Delivery to Day 90 post-delivery (Infant follow-up))
- Number of Infants Born Live, Reported Sick and Brought to a Study or Non-study Health Care Facility Site.(Delivery to Day 90 post-delivery (Infant follow-up))