Serum Concentrations of Pregnancy-associated Proteins for Assessment of Gestational Age Before Abortion
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 275
- 试验地点
- 3
- 主要终点
- Negative Predictive Value 105 days
研究概览
简要总结
This will be a case-series multicenter study enrolling 800 pregnant people. Serum will be collected from people seeking abortion and assayed at a qualified laboratory.
详细描述
Knowledge of gestational age (GA) is essential for guiding abortion care. In 2016, Gynuity Health Projects (GHP) launched a portfolio of research that aims to explore the possibility of developing a blood or urine test for this purpose.The goal of the present study is to validate initial study findings (protocol 8000) in a larger population of people seeking abortion.
Staff will obtain a serum specimen from each participant before any cervical manipulation is performed and before any abortifacient drug is administered. The site will send the specimens to a central facility for storage until assay. Serum assays for PAPP-A and possibly other proteins will be performed at a selected laboratory by qualified experts.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant and seeking medical or surgical abortion
- •Has had or will have an ultrasound on the day of study enrollment or earlier during the current pregnancy
- •Able to provide blood and urine specimens before any trans-cervical procedure or mifepristone ingestion
- •Not previously enrolled in this study
排除标准
- •Does not meet Inclusion Criteria
结局指标
主要结局
Negative Predictive Value 105 days
时间窗: 1 day
Negative Predictive Value of Prespecified Protein Concentration in Serum for Predicting a GA of ≤105 days is \>95%
Negative Predictive Value 70 days
时间窗: 1 day
Negative Predictive Value of Prespecified Protein Concentration in Serum for Predicting a GA of ≤70 days is \>95%
次要结局
未报告次要终点