Assessment of Biomarkers in Ectopic Pregnancy

Recruiting

• Conditions: Ectopic Pregnancy
• Interventions: Other: Management of termination of pregnancy; Other: Management of Ectopic Pregnancy; Other: Elective management of gynaecology patients

• Registration Number: NCT04176549
• Lead Sponsor: Imperial College London

Brief 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-11-18
• Study First Submitted: 2019-11-20
• Study First Submitted QC: 2019-11-21
• Study First Posted: 2019-11-25
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-06
• Last Update Posted: 2022-07-07
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Surgical termination of pregnancy	Management of termination of pregnancy	Patients undergoing elective surgical termination of pregnancy Samples collected: Plasma, Serum, Urine, Oral swab Vaginal swab, Trophoblast
Ectopic Pregnancy	Management of 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
Elective hysterectomy and salpingo-oophorectomy	Elective management of gynaecology patients	Patients undergoing elective hysterectomy and salpingo-oophorectomy Samples collected: Fallopian tube, peritoneal washing

Primary Outcome Measures

Name	Time	Method
Novel biomarkers for Ectopic Pregnancy prediction and diagnosis	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.

Secondary Outcome Measures

Name	Time	Method
microRNA as a biomarker	3 years	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.
Microbiome as a biomarker	3 years	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.

Trial Locations

Locations (1)

Imperial College Healthcare NHS Trust; 🇬🇧 London, United Kingdom