Ectopic PregnancyAMBERNCT04176549
Assessment of Biomarkers in Ectopic Pregnancy
An observational study of Ectopic Pregnancy, run by Imperial College London at 1 site in United Kingdom.
Trial summary
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. 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
- Ectopic Pregnancy
- What is being tested?
- Management of Ectopic Pregnancy, Management of termination of pregnancy and Elective management of gynaecology patients
- Type of treatment
- Pill or oral medicine
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Nov 2019to 31 Dec 2025
- 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. * Women attending the gynaecology unit for a surgical termination of pregnancy or for a salpingo-oophorectomy.
Who may be able to join
- 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.
Who cannot join
- 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.
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
Official title: The 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.
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. 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.
- Conditions
- Ectopic Pregnancy
- Being tested
- Management of Ectopic Pregnancy, Management of termination of pregnancy, Elective management of gynaecology patients
- Keywords
- Ectopic Pregnancy, Biomarker
- Medical subject headings
- Pregnancy, Ectopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Management of Ectopic PregnancyOther
Expectant, Medical or Surgical management of Ectopic Pregnancy
Management of termination of pregnancyOther
Surgical termination of pregnancy
Elective management of gynaecology patientsOther
Elective hysterectomy and salpingo-oophorectomy
| Study group | Role | What they receive |
|---|---|---|
| Ectopic Pregnancy | Patients diagnosed with ectopic pregnancy Samples collected: Plasma, Serum, Urine, Oral swab, Vaginal Swab If surgery required for tubal ectopic: Fallopian tube, peritoneal washing, trophoblast Receives: Other: Management of Ectopic Pregnancy | |
| Surgical termination of pregnancy | Patients undergoing elective surgical termination of pregnancy Samples collected: Plasma, Serum, Urine, Oral swab Vaginal swab, Trophoblast Receives: Other: Management of termination of pregnancy | |
| Elective hysterectomy and salpingo-oophorectomy | Patients undergoing elective hysterectomy and salpingo-oophorectomy Samples collected: Fallopian tube, peritoneal washing Receives: Other: Elective management of gynaecology patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Novel biomarkers for Ectopic Pregnancy prediction and diagnosis
Identification of microRNA and microbiome markers identified in blood, urine, swabs, fallopian tubes, peritoneal washings and trophoblastic tissue that have predictive value in identifying ectopic pregnancies as well as high and low risk pregnancy of unknown location. microRNA will be assessed using blood and trophoblast using cell free profiling assays and quantitative reverse transcription polymerase chain reaction and microbiome will be assessed using Illumina microbiome genomic sequencing.
Measured: 3 years
Secondary outcomes (2)
microRNA as a biomarker
Identification of novel microRNA markers from blood and trophoblast tissue samples associated with ectopic pregnancy and high-risk pregnancy of unknown location. MicroRNA will be assessed using blood and trophoblast using cell free profiling assays and quantitative reverse transcription polymerase chain reaction.
Measured: 3 years
Microbiome as a biomarker
Identification of novel microbiome markers from blood and trophoblast tissue samples associated with ectopic pregnancy and high-risk pregnancy of unknown location. Microbiome will be assessed using Illumina microbiome genomic sequencing.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2019
- Study start18 Nov 2019
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Ectopic PregnancyStudies 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
- 200 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
- Investigators
- Tom Bourne, MBBS, PhD, MRCOG, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04176549
- Sponsor's protocol ID
- 18HH4883
- Acronym
- AMBER
- Status last verified
- Jul 2022
- First submitted
- 20 Nov 2019
- Last updated
- 7 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bobdiwala S, Al-Memar M, Farren J, Bourne T. Factors to consider in pregnancy of unknown location. Womens Health (Lond). 2017 Aug;13(2):27-33. doi: 10.1177/1745505717709677. Epub 2017 Jun 29.
PubMed 28660799Senapati S, Barnhart KT. Biomarkers for ectopic pregnancy and pregnancy of unknown location. Fertil Steril. 2013 Mar 15;99(4):1107-16. doi: 10.1016/j.fertnstert.2012.11.038. Epub 2013 Jan 3.
PubMed 23290746Van Calster B, Bobdiwala S, Guha S, Van Hoorde K, Al-Memar M, Harvey R, Farren J, Kirk E, Condous G, Sur S, Stalder C, Timmerman D, Bourne T. Managing pregnancy of unknown location based on initial serum progesterone and serial serum hCG levels: development and validation of a two-step triage protocol. Ultrasound Obstet Gynecol. 2016 Nov;48(5):642-649. doi: 10.1002/uog.15864. Epub 2016 Oct 9.
PubMed 26776599Bobdiwala S, Christodoulou E, Farren J, Mitchell-Jones N, Kyriacou C, Al-Memar M, Ayim F, Chohan B, Kirk E, Abughazza O, Guruwadahyarhalli B, Guha S, Vathanan V, Bottomley C, Gould D, Stalder C, Timmerman D, van Calster B, Bourne T. Triaging women with pregnancy of unknown location using two-step protocol including M6 model: clinical implementation study. Ultrasound Obstet Gynecol. 2020 Jan;55(1):105-114. doi: 10.1002/uog.20420.
PubMed 31385381Cook J, Bennett PR, Kim SH, Teoh TG, Sykes L, Kindinger LM, Garrett A, Binkhamis R, MacIntyre DA, Terzidou V. First Trimester Circulating MicroRNA Biomarkers Predictive of Subsequent Preterm Delivery and Cervical Shortening. Sci Rep. 2019 Apr 10;9(1):5861. doi: 10.1038/s41598-019-42166-1.
PubMed 30971726
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Assessment of Biomarkers in Ectopic Pregnancy
- ClinicalTrials.gov ID
- NCT04176549
- Acronym / sponsor ID
- AMBER / 18HH4883
- Conditions
- Ectopic Pregnancy
- Keywords
- Ectopic Pregnancy, Biomarker
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Imperial College Healthcare NHS Trust
- Study start
- 18 Nov 2019 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 25 Nov 2019 (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 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.
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. 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ectopic Pregnancy | – | Other: Management of Ectopic PregnancyPatients diagnosed with ectopic pregnancy Samples collected: Plasma, Serum, Urine, Oral swab, Vaginal Swab If surgery required for tubal ectopic: Fallopian tube, peritoneal washing, trophoblast |
| Surgical termination of pregnancy | – | Other: Management of termination of pregnancyPatients undergoing elective surgical termination of pregnancy Samples collected: Plasma, Serum, Urine, Oral swab Vaginal swab, Trophoblast |
| Elective hysterectomy and salpingo-oophorectomy | – | Other: Elective management of gynaecology patientsPatients undergoing elective hysterectomy and salpingo-oophorectomy Samples collected: Fallopian tube, peritoneal washing |
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. * Women attending the gynaecology unit for a surgical termination of pregnancy or for a salpingo-oophorectomy.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Management of Ectopic PregnancyExpectant, Medical or Surgical management of Ectopic Pregnancy | Other | Ectopic Pregnancy |
| Management of termination of pregnancySurgical termination of pregnancy | Other | Surgical termination of pregnancy |
| Elective management of gynaecology patientsElective hysterectomy and salpingo-oophorectomy | Other | Elective hysterectomy and salpingo-oophorectomy |
Primary outcome
Novel biomarkers for Ectopic Pregnancy prediction and diagnosis
Time frame: 3 years
Identification of microRNA and microbiome markers identified in blood, urine, swabs, fallopian tubes, peritoneal washings and trophoblastic tissue that have predictive value in identifying ectopic pregnancies as well as high and low risk pregnancy of unknown location. microRNA will be assessed using blood and trophoblast using cell free profiling assays and quantitative reverse transcription polymerase chain reaction and microbiome will be assessed using Illumina microbiome genomic sequencing.
2 secondary outcomes
microRNA as a biomarker
Time frame: 3 years
Microbiome as a biomarker
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2022.
- Background: PubMed 28660799Bobdiwala S, Al-Memar M, Farren J, Bourne T. Factors to consider in pregnancy of unknown location. Womens Health (Lond). 2017 Aug;13(2):27-33. doi: 10.1177/1745505717709677. Epub 2017 Jun 29.
- Background: PubMed 23290746Senapati S, Barnhart KT. Biomarkers for ectopic pregnancy and pregnancy of unknown location. Fertil Steril. 2013 Mar 15;99(4):1107-16. doi: 10.1016/j.fertnstert.2012.11.038. Epub 2013 Jan 3.
- Background: PubMed 26776599Van Calster B, Bobdiwala S, Guha S, Van Hoorde K, Al-Memar M, Harvey R, Farren J, Kirk E, Condous G, Sur S, Stalder C, Timmerman D, Bourne T. Managing pregnancy of unknown location based on initial serum progesterone and serial serum hCG levels: development and validation of a two-step triage protocol. Ultrasound Obstet Gynecol. 2016 Nov;48(5):642-649. doi: 10.1002/uog.15864. Epub 2016 Oct 9.
- Background: PubMed 31385381Bobdiwala S, Christodoulou E, Farren J, Mitchell-Jones N, Kyriacou C, Al-Memar M, Ayim F, Chohan B, Kirk E, Abughazza O, Guruwadahyarhalli B, Guha S, Vathanan V, Bottomley C, Gould D, Stalder C, Timmerman D, van Calster B, Bourne T. Triaging women with pregnancy of unknown location using two-step protocol including M6 model: clinical implementation study. Ultrasound Obstet Gynecol. 2020 Jan;55(1):105-114. doi: 10.1002/uog.20420.
- Background: PubMed 30971726Cook J, Bennett PR, Kim SH, Teoh TG, Sykes L, Kindinger LM, Garrett A, Binkhamis R, MacIntyre DA, Terzidou V. First Trimester Circulating MicroRNA Biomarkers Predictive of Subsequent Preterm Delivery and Cervical Shortening. Sci Rep. 2019 Apr 10;9(1):5861. doi: 10.1038/s41598-019-42166-1.
- 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.
Tom Bourne, MBBS, PhD, MRCOG principal investigator
Imperial College London
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 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 2 inclusion and 4 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 7 Jul 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?
Novel biomarkers for Ectopic Pregnancy prediction and diagnosis (time frame: 3 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 NCT04176549, which also lists 5 linked publications.
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 7 Jul 2022.