Assessment of Biomarkers in Pregnancy on Unknown Location and Ectopic Pregnancy

Study Overview
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Brief Summary
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To further develop the patient care pathway for women classified with a pregnancy of unknown location (PUL) and ectopic pregnancy (EP).

Detailed Description
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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.

Official Title
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Assessment of Biomarkers in Pregnancy on Unknown Location and Ectopic Pregnancy

Conditions
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Pregnancy of Unknown Location, Ectopic Pregnancy, Early Pregnancy, Early Pregnancy Loss

Intervention / Treatment
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* Other: Sample collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnancy of unknown location<br>Patients will be approached for recruitment following PUL classification. Sample collection at time of classification +/- 48 hours later, timed for when bloods are taken as part of routine clinical practice +/- at any time patient attends for clinically indicated blood samples. | Other: Sample collection<br>* Bloods +/- urine +/- vaginal swabs taken<br>|
| Ectopic Pregnancy<br>Patients will be approached for recruitment following Ectopic Pregnancy diagnosis. Ectopic pregnancies that are recruited as PUL do not need to be re-approached as they are already part of the study. Sample collection at time of diagnosis when bloods are taken as part of routine clinical practice +/- at any time patient attends for clinically indicated blood samples. | Other: Sample collection<br>* Bloods +/- urine +/- vaginal swabs taken<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PUL outcome prediction | The number of PUL patients correctly categorised as 'low risk' or 'high risk' based on the new logistical regression model | 7 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 7 years | 
| BhCG timing | Whether the timing of serial BhCG measurements has a significant impact on the risk stratification of PUL patients | 7 years | 
| Novel biomarkers | Whether a novel candidate metabolite may have predictive value in determining 'low risk' versus 'high risk' PUL | 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 | 7 years |