PROmega Pilot Study of Clinic-based DHA Blood Screening in Early Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 650
- 试验地点
- 1
- 主要终点
- Screening uptake percentage
研究概览
简要总结
This pilot study will explore feasibility of routine implementation of the recommended blood-based screening of DHA status in early pregnancy in routine clinical care.
详细描述
This pilot study will be conducted within the Atrium Health Wake Forest Baptist general academic obstetric practice that serves patients in six clinic locations in the Winston-Salem area. The study will train clinical staff on the prenatal omega-3 evidence; work with Epic IT to add the DHA blood test to the early prenatal lab order set; provide screening results with interpretation to patients and clinicians via Epic; monitor uptake of screening and viewing of results; and review screening results and characteristics of screened patients. This pilot data will inform the design of a cluster randomized trial to compare DHA blood screening with US usual care on preterm birth outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients initiating prenatal care at participating clinics who are eligible for early pregnancy blood testing per American College of Obstetricians and Gynecologists (ACOG) standards
排除标准
- 未提供
研究组 & 干预措施
DHA blood screening
Measurement of DHA as percent of total fatty acids in red blood cells
干预措施: DHA blood screening (Other)
结局指标
主要结局
Screening uptake percentage
时间窗: First 20 weeks of pregnancy
Percent of eligible patients who receive DHA screening
次要结局
未报告次要终点