Detection of Preterm Prelabour Rupture of Membranes With AmniSure Placental Alpha Macroglobulin-1 Rapid Immunoassay
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- accuracy of Amnisure vs conventional testing for PPROM
研究概览
简要总结
The investigators will test the hypothesis that in a preterm population with a gestational age of 16+0 and 36+6 weeks AmniSure PAMG-1 rapid immunoassay will be more accurate than conventional methods (speculum examination for combination of pooling, nitrazine and ferning) for the detection of Preterm Prelabour Rupture of Membranes (PROM).
详细描述
Prior studies of AmniSure have included a heterogeneous population of women with preterm and term pregnancies.10-12 No study to date has specifically addressed and been powered to detect the efficacy of AmniSure in pregnancies between 16+0 and 36+6 weeks. The objective of the proposed research is to evaluate the usefulness of AmniSure PAMG-1 rapid immunoassay in the evaluation of preterm prelabour rupture of membranes (PPROM) compared to standard detection of PPROM with a speculum examination for combination of pooling, nitrazine and ferning.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women presenting to assessment at the labour and delivery unit at RUH with suspected PPROM between 16+0 and 36+6 weeks gestation
- •consent to enrollment
排除标准
- •vaginal bleeding
- •active labor (cervical dilation > 2 cm or effacement > 80%)
- •multiple pregnancy
- •fetal anomalies
- •placenta previa
- •fluid loss per vagina > 7 days
- •prior inclusion in the study
结局指标
主要结局
accuracy of Amnisure vs conventional testing for PPROM
时间窗: up to 24 weeks
After delivery, the charts will be reviewed and information will be used to determine the final diagnosis of membrane status as ruptured or intact on initial presentation and will be used to evaluate the accuracy of the AmniSure test results.
次要结局
未报告次要终点
研究者
Sabrina Stewart
Principal Investigator
University of Saskatchewan