Assessment of Biomarkers in Ectopic Pregnancy
Assessment of Biomarkers in Ectopic Pregnancy
To further develop a patient care pathway (incorporating a statistical model which uses the
 values of biomarkers) in routine clinical practice that will aid the diagnosis and management
 of women with an ectopic pregnancy.
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. These markers
 may replace or add to the effectiveness of markers used in the current statistical model.

 Recruitment-200 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 for all aspects of the
 study other than for 3-dimensional scanning of PUL and EP patients, where verbal consent will
 be obtained. Patients will be given at least 24 hours to consider whether they wish to
 participate.

 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.
Inclusion Criteria:

 -  Patients attending the Early Pregnancy Unit (EPU) in the first trimester (up to 14
 weeks gestation) with a PUL or ectopic pregnancy on trans-vaginal ultrasound scan
 between the ages of 18 and 50 years.

 -  Patients attending the gynaecology unit for a surgical termination of pregnancy or for
 a salpingo-oophorectomy.

 Exclusion Criteria:

 -  Patients diagnosed with cancer, presence of an acute medical condition, patients aged
 less than 18 years, patients who cannot give fully informed study consent (language or
 learning impairment), presence of a viable intrauterine pregnancy and presence of
 miscarriage.

 -  Exclusion to fallopian tube samples - presence of any ectopic pregnancy that does not
 require operative salpingectomy.

 -  Exclusion to peritoneal washings - presence of any ectopic pregnancy that does not
 require access to the peritoneal cavity as part of management.

 -  Exclusion to trophoblast tissue sampling - presence of an ectopic pregnancy that does
 not require surgical removal.