Brief Title
Assessment of Biomarkers in Pregnancy on Unknown Location and Ectopic Pregnancy
Official Title
Assessment of Biomarkers in Pregnancy on Unknown Location and Ectopic Pregnancy
Brief Summary
To further develop the patient care pathway for women classified with a pregnancy of unknown
location (PUL) and ectopic pregnancy (EP).
Detailed Description
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
Primary Outcome
PUL outcome prediction
Secondary Outcome
Urinary BhCG and PUL
Condition
Pregnancy of Unknown Location
Intervention
Sample collection
Study Arms / Comparison Groups
Pregnancy of unknown location
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
1000
Start Date
December 8, 2014
Completion Date
December 31, 2024
Primary Completion Date
December 31, 2024
Eligibility Criteria
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
Gender
Female
Ages
18 Years - 50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
, 0044 203 313 5131, [email protected]
Location Countries
United Kingdom
Location Countries
United Kingdom
Administrative Informations
NCT ID
NCT04738370
Organization ID
14HH2202
Responsible Party
Sponsor
Study Sponsor
Imperial College London
Collaborators
Imperial College Healthcare NHS Trust
Study Sponsor
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Verification Date
March 2022