Assessing biomarkers to improve diagnosis and management of ectopic pregnancy
The Assessment of Biomarkers in Ectopic Pregnancy
This study is testing new biomarkers to see if they can help doctors better diagnose and manage ectopic pregnancies in women who have early pregnancy concerns.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Imperial College London Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT04176549 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance the patient care pathway for women experiencing ectopic pregnancy or pregnancy of unknown location by incorporating a statistical model that utilizes novel biomarkers. The goal is to improve diagnostic accuracy and management strategies in routine clinical practice. The study will recruit 200 patients attending the Early Pregnancy Unit, focusing on those with specific ultrasound findings. Participants will provide informed consent, and their data will be used to identify effective biomarkers that could replace or supplement existing diagnostic markers.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-50 who are attending the Early Pregnancy Unit with a pregnancy of unknown location or an ectopic pregnancy.
Not a fit: Patients with cancer, acute medical conditions, or those under 18 years old will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate diagnoses and better management of ectopic pregnancies, ultimately improving patient outcomes.
How similar studies have performed: Other studies have shown promise in using biomarkers for diagnosing ectopic pregnancies, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
London
- Imperial College Healthcare NHS Trust — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Tom Bourne, MBBS, PhD, MRCOG — Imperial College London
- Study coordinator: Tom Bourne, MBBS, PhD, MRCOG
- Email: t.bourne@ic.ac.uk
- Phone: 0044 203 313 5131
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.