An observational study in Pregnancy of Unknown Location, Ectopic Pregnancy and Early Pregnancy, sponsored by Imperial College London. Status unknown at 1 site in United Kingdom. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-01.
Sponsored by Imperial College London · Observational
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.
83 studies on the registry are indexed under Pregnancy, Ectopic; 21 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 150 across 39 observational studies indexed under Pregnancy, Ectopic.
Browse Pregnancy, Ectopic studies →Imperial College London is the lead sponsor of 843 studies on the registry; 180 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Pregnant women attending the Early Pregnancy Unit (EPU) within a hospital 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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Bloods +/- urine +/- vaginal swabs taken
PUL 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
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
Plan to share: Undecided
No publications or documents are linked to this record.
Started Dec 2014 (actual). Primary completion is estimated for Dec 2024, 120 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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