To further develop the patient care pathway for women classified with a pregnancy of unknown location (PUL) and ectopic pregnancy (EP).
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.
Study Type
OBSERVATIONAL
Enrollment
1,000
Bloods +/- urine +/- vaginal swabs taken
Imperial College Healthcare NHS Trust
London, United Kingdom
RECRUITINGPUL outcome prediction
The number of PUL patients correctly categorised as 'low risk' or 'high risk' based on the new logistical regression model
Time frame: 7 years
Urinary BhCG and PUL
The number of PUL patients correctly categorised as 'low risk' or 'high risk' based on the interpretation of urine (rather than serum) BhCG
Time frame: 7 years
Urine BhCG and Ectopic pregnancy
The number of ectopic pregnancies correctly risk stratified as being suitable for expectant or medical management based on the interpretation of urine (rather than serum) BhCG
Time frame: 7 years
Plasma and Serum and PUL
Whether novel biomarkers present in serum and/or plasma and/or urine may have predictive value in determining 'low risk' versus 'high risk' PUL
Time frame: 7 years
Plasma and Serum and Ectopic pregnancy
Whether novel biomarkers present in serum and/or plasma and/or urine may have predictive value in determining which women diagnosed with an ectopic pregnancy are suitable for expectant or medical management
Time frame: 7 years
BhCG timing
Whether the timing of serial BhCG measurements has a significant impact on the risk stratification of PUL patients
Time frame: 7 years
Novel biomarkers
Whether a novel candidate metabolite may have predictive value in determining 'low risk' versus 'high risk' PUL
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Time frame: 7 years
Other novel biomarkers
Whether a novel candidate metabolite may have predictive value in determining which women diagnosed with an ectopic pregnancy are suitable for expectant or medical management
Time frame: 7 years