Evaluation of the Clinical Performance of the PremaSure Kit to Assess Premature Delivery Risk in Symptomatic Pregnant Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Evaluation of the clinical performance of the PremaSure kit
研究概览
简要总结
The goal of the study is to determine the clinical performance of the PremaSure kit, more precisely to assess whether the PremaSure kit can be used as a self-test to assess the risk of premature delivery in patients showing symptoms of premature delivery. The sensitivity and specificity of the test will be determined using as an outcome the delivery of the patient in the 7/14 days following the test.
The simplified procedure is the following:
- Patients are recruited and screened for eligibility criteria
- A healthcare professional collects a vaginal swab from the patient
- The collected sample is tested on the PremaSure kit
- Pregnancy outcome is compared to the PremaSure kit's result
详细描述
Introduction:
Preterm birth is the first cause of death of infants below five years old. One of the key strategies to save preterm babies is to effectively identify women at risk of preterm birth. While current solutions for the assessment of prematurity risk rely on invasive examination performed by medical professional, the PremaSure is intended to be used by lay user, empowering them with a tool to monitor their pregnancy.
Measurement and procedures:
Consenting patient meeting all the inclusion and none of the exclusion critera will be swabbed by a healthcare professional to collect vaginal secretions. A study nurse will perform the test per the test's IFU. Information related to the patient's delivery will be collected after term to evaluate the predictive performance of the PremaSure kit.
Withdrawal and discontinuation:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Informed Consent signed by the subject
- •Female patients above 18 years
- •Gestational week from 22w+0 days to 35w+6 days
- •Symptoms of prematurity.
排除标准
- •Subject lacking capacity to provide informed consent
- •Enrolment of the project leader, their family members, employees and other dependent persons
- •Patients with ruptured amniotic membranes or blood in their vaginal discharge
- •Patients with vaginal examination in the last 24 hours
- •Previous enrolment in the current study
结局指标
主要结局
Evaluation of the clinical performance of the PremaSure kit
时间窗: From enrollment to the delivery of the patient
On the population of patients who have fully completed the study without experiencing a non-spontaneous delivery up to 14 days after the sample collection, we will determine the sensitivity, specificity, accuracy, positive and negative predictive values (PPV and NPV respectively) of the PremaSure test for the identification of pregnant women at risk of pre-term delivery at 7 and 14 days, respectively
次要结局
- Estimation of the clinical performance of the PremaSure kit on sub-group population(From enrollment until the delivery of the patient)
- Estimation of correlation coefficients between the participant pregnancy information and the outcome of the pregnancy(From enrollment until delivery of the patient.)