Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
200 participants
OBSERVATIONAL
2019-11-18
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Effect of Different Treatment Modalities of Tubal Ectopic Pregnancy on Ovarian Reserve: a Prospective Cohort Study
NCT06471166
Novel Diagnosis of Ectopic Pregnancy
NCT06486415
Different Treatment Options for Tubal Ectopic Pregnancy:- A Systmatic Review
NCT04951011
The Selection of Pregnancy for Patients After Tubal Ectopic Pregnancy Treatment
NCT05498558
Pregnancies of Uncertain Location or Viability Research
NCT02700789
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
Management of Ectopic Pregnancy
Expectant, Medical or Surgical 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
Management of termination of pregnancy
Surgical termination of pregnancy
Elective hysterectomy and salpingo-oophorectomy
Patients undergoing elective hysterectomy and salpingo-oophorectomy Samples collected: Fallopian tube, peritoneal washing
Elective management of gynaecology patients
Elective hysterectomy and salpingo-oophorectomy
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Management of Ectopic Pregnancy
Expectant, Medical or Surgical management of Ectopic Pregnancy
Management of termination of pregnancy
Surgical termination of pregnancy
Elective management of gynaecology patients
Elective hysterectomy and salpingo-oophorectomy
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients attending the gynaecology unit for a surgical termination of pregnancy or for a salpingo-oophorectomy.
Exclusion Criteria
* 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.
18 Years
50 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Imperial College Healthcare NHS Trust
OTHER
Imperial College London
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Tom Bourne, MBBS, PhD, MRCOG
Role: PRINCIPAL_INVESTIGATOR
Imperial College London
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Imperial College Healthcare NHS Trust
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Senapati 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.
Van 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.
Bobdiwala 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.
Cook 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
18HH4883
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.