An observational study in Ectopic Pregnancy, sponsored by Imperial College London. Recruiting at 1 site in United Kingdom. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-07.
Sponsored by Imperial College London · Observational
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.
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.
83 studies on the registry are indexed under Pregnancy, Ectopic; 21 are open to participants now.
This study's planned enrollment of 200 is above the median of 150 across 39 observational studies indexed under Pregnancy, Ectopic.
Browse Pregnancy, Ectopic studies →Imperial College London is the lead sponsor of 843 studies on the registry; 180 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
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Exclusion Criteria:
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
Other: Management of Ectopic Pregnancy
Patients undergoing elective surgical termination of pregnancy Samples collected: Plasma, Serum, Urine, Oral swab Vaginal swab, Trophoblast
Other: Management of termination of pregnancy
Patients undergoing elective hysterectomy and salpingo-oophorectomy Samples collected: Fallopian tube, peritoneal washing
Other: Elective management of gynaecology patients
Expectant, Medical or Surgical management of Ectopic Pregnancy
Surgical termination of pregnancy
Elective hysterectomy and salpingo-oophorectomy
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.
Time frame: 3 years
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.
Time frame: 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.
Time frame: 3 years
Plan to share: Undecided
Started Nov 2019 (actual). Primary completion is estimated for Dec 2025, 73 months after the start.
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