Clinical trial NCT04738370: Assessment of Biomarkers in Pregnancy on Unknown Location and Ectopic Pregnancy
Official title: Assessment of Biomarkers in Pregnancy on Unknown Location and Ectopic Pregnancy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy of Unknown Location
Ectopic Pregnancy
Early Pregnancy
Early Pregnancy Loss
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Imperial College Healthcare NHS Trust
First posted: 2021-02-04
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief summary: To further develop the patient care pathway for women classified with a pregnancy of unknown location (PUL) and ectopic pregnancy (EP).

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.

Recruitment-1000 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.

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.

Eligibility criteria: Inclusion Criteria:

* Patients attending the Early Pregnancy Unit in the first trimester of pregnancy (≤14 weeks gestation) aged between 18-50 years old and categorized as having a PUL or ectopic pregnancy

Exclusion Criteria:

* Younger than 18 years of age
* Women who in the opinion of the researcher by virtue of language or learning impairment would be unable to give fully informed consent to the study
* Viable intrauterine pregnancy (the presence of a fetal pole with a fetal heartbeat within the uterine cavity)
* Miscarriage
* Presence of an acute medical condition

Primary outcomes:
measure: PUL outcome prediction
timeFrame: 7 years
Secondary outcomes:
measure: Urinary BhCG and PUL
timeFrame: 7 years
measure: Urine BhCG and Ectopic pregnancy
timeFrame: 7 years
measure: Plasma and Serum and PUL
timeFrame: 7 years
measure: Plasma and Serum and Ectopic pregnancy
timeFrame: 7 years
measure: BhCG timing
timeFrame: 7 years
measure: Novel biomarkers
timeFrame: 7 years
measure: Other novel biomarkers
timeFrame: 7 years
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
Study officials:
References: