Assessment of Biomarkers in Pregnancy on Unknown Location and Ectopic Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- PUL outcome prediction
研究概览
简要总结
To further develop the patient care pathway for women classified with a pregnancy of unknown location (PUL) and ectopic pregnancy (EP).
详细描述
Purpose and design-There is a need for the patient care pathway to evolve in order to aid and improve the diagnosis and management of women with a pregnancy of unknown location (PUL) and ectopic pregnancy (EP). There is potential for this to be achieved by the incorporation of a statistical model that uses one or more novel markers identified by this study.
Recruitment-1000 patients. Inclusion: Patients attending the Early Pregnancy Unit (EPU) in the first trimester with a PUL or ectopic pregnancy on trans-vaginal ultrasound scan between the ages of 18-50 years. Exclusion: Patients diagnosed with cancer, presence of acute medical condition, patients aged less than 18 years, patients who cannot give fully informed study consent.
Consent - Posters will advertise the study. Patients in EPU will be invited to the study by a member of the clinical care team. Written consent will be required.
Confidentiality - The Chief Investigator will preserve the confidentiality of participants taking part in the study and is registered under the Data Protection Act. Patient consent forms will be stored securely within the study file. All patient identifiable information, where required, will be stored electronically on National Health Service (NHS) approved computers, accessible only by personnel involved in the study via password.
Conflict of interest - None involved in the study have a conflict of interest. Dissemination of results - No patient identifiable information will be included in the research report or publication. Anonymised results will be disseminated to scientific community by means of publication in peer-reviewed literature and presented at national and international meetings.
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients attending the Early Pregnancy Unit in the first trimester of pregnancy (≤14 weeks gestation) aged between 18-50 years old and categorized as having a PUL or ectopic pregnancy
排除标准
- •Younger than 18 years of age
- •Women who in the opinion of the researcher by virtue of language or learning impairment would be unable to give fully informed consent to the study
- •Viable intrauterine pregnancy (the presence of a fetal pole with a fetal heartbeat within the uterine cavity)
- •Miscarriage
- •Presence of an acute medical condition
结局指标
主要结局
PUL outcome prediction
时间窗: 7 years
The number of PUL patients correctly categorised as 'low risk' or 'high risk' based on the new logistical regression model
次要结局
- Urine BhCG and Ectopic pregnancy(7 years)
- BhCG timing(7 years)
- Urinary BhCG and PUL(7 years)
- Plasma and Serum and PUL(7 years)
- Plasma and Serum and Ectopic pregnancy(7 years)
- Novel biomarkers(7 years)
- Other novel biomarkers(7 years)