Pregnancy of Unknown LocationABPEPNCT04738370
Assessment of Biomarkers in Pregnancy on Unknown Location and Ectopic Pregnancy
An observational study of Pregnancy of Unknown Location and Ectopic Pregnancy, run by Imperial College London at 1 site in United Kingdom.
Trial summary
To further develop the patient care pathway for women classified with a pregnancy of unknown location (PUL) and ectopic pregnancy (EP). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy of Unknown Location, Ectopic Pregnancy, Early Pregnancy
- What is being tested?
- Sample collection
- How many people
- 1,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Dec 2014to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Imperial College Healthcare NHS Trust
London, W12 0HS
Tom Bourne, MBBS, PhD, MRCOG, 0044 203 313 5131, t.bourne@ic.ac.uk
Christopher Kyriacou, MBBS, BSc, 0044 203 313 5131, christopher.kyriacou@nhs.net
About this study
To further develop the patient care pathway for women classified with a pregnancy of unknown location (PUL) and ectopic pregnancy (EP).
Read the 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.
- Being tested
- Sample collection
- Medical subject headings
- Pregnancy, Ectopic, Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sample collectionOther
Bloods +/- urine +/- vaginal swabs taken
| Study group | Role | What they receive |
|---|---|---|
| Pregnancy of unknown location | 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. Receives: Other: Sample collection | |
| Ectopic Pregnancy | 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. Receives: Other: Sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
PUL outcome prediction
The number of PUL patients correctly categorised as 'low risk' or 'high risk' based on the new logistical regression model
Measured: 7 years
Secondary outcomes (7)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 7 years
BhCG timing
Whether the timing of serial BhCG measurements has a significant impact on the risk stratification of PUL patients
Measured: 7 years
Novel biomarkers
Whether a novel candidate metabolite may have predictive value in determining 'low risk' versus 'high risk' PUL
Measured: 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
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start8 Dec 2014
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy of Unknown LocationStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College Healthcare NHS Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04738370
- Sponsor's protocol ID
- 14HH2202
- Acronym
- ABPEP
- Status last verified
- Mar 2022
- First submitted
- 1 Feb 2021
- Last updated
- 1 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kyriacou C, Yang W, Kapur S, Maheetharan S, Pikovsky M, Parker N, Barcroft J, Bobdiwala S, Sur S, Stalder C, Gould D, Ofili-Yebovi D, Day A, Unsworth N, Wilkes EH, Tan T, Bourne T. Ambulatory human chorionic gonadotrophin (hCG) testing: a verification of two hCG point of care devices. Clin Chem Lab Med. 2023 Oct 30;62(4):664-673. doi: 10.1515/cclm-2023-0703. Print 2024 Mar 25.
PubMed 37886834
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Biomarkers in Pregnancy on Unknown Location and Ectopic Pregnancy
- ClinicalTrials.gov ID
- NCT04738370
- Acronym / sponsor ID
- ABPEP / 14HH2202
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Imperial College Healthcare NHS Trust
- Study start
- 8 Dec 2014 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 4 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnancy of unknown location | – | Other: Sample collectionPatients 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. |
| Ectopic Pregnancy | – | Other: Sample collectionPatients 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sample collectionBloods +/- urine +/- vaginal swabs taken | Other | Ectopic Pregnancy, Pregnancy of unknown location |
Primary outcome
PUL outcome prediction
Time frame: 7 years
The number of PUL patients correctly categorised as 'low risk' or 'high risk' based on the new logistical regression model
7 secondary outcomes
Urinary BhCG and PUL
Time frame: 7 years
Urine BhCG and Ectopic pregnancy
Time frame: 7 years
Plasma and Serum and PUL
Time frame: 7 years
Plasma and Serum and Ectopic pregnancy
Time frame: 7 years
BhCG timing
Time frame: 7 years
Novel biomarkers
Time frame: 7 years
Other novel biomarkers
Time frame: 7 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2022.
- Derived from this study: PubMed 37886834Kyriacou C, Yang W, Kapur S, Maheetharan S, Pikovsky M, Parker N, Barcroft J, Bobdiwala S, Sur S, Stalder C, Gould D, Ofili-Yebovi D, Day A, Unsworth N, Wilkes EH, Tan T, Bourne T. Ambulatory human chorionic gonadotrophin (hCG) testing: a verification of two hCG point of care devices. Clin Chem Lab Med. 2023 Oct 30;62(4):664-673. doi: 10.1515/cclm-2023-0703. Print 2024 Mar 25.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy of Unknown Location and Ectopic Pregnancy, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tom Bourne, MBBS, PhD, MRCOG (0044 203 313 5131, t.bourne@ic.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PUL outcome prediction (time frame: 7 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04738370, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2022.