Assessment of Biomarkers in Pregnancy on Unknown Location and Ectopic Pregnancy

Study Results

Results pending

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.

Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-08

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Optimal Treatment for Women With a Persisting Pregnancy of Unknown Location

NCT02152696

Persistent Pregnancy of Unknown Location Ectopic Pregnancy

COMPLETED PHASE3

RCT for Women With a Persisting Pregnancy of Unknown Location

NCT01800162

Persistent Pregnancy of Unknown Location Ectopic Pregnancy

TERMINATED PHASE1/PHASE2

Risk Factors of Ectopic Pregnancy

NCT00194207

Ectopic Pregnancy

COMPLETED

Management of Pregnancies of Unknown Location (PUL)

NCT03461835

Pregnancy, Ectopic Pregnancy, High Risk Pregnancy Early

COMPLETED NA

Ectopic Pregnancy Biomarkers

NCT00194168

Ectopic Pregnancy

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pregnancy of Unknown Location Ectopic Pregnancy Early Pregnancy Early Pregnancy Loss

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pregnancy of unknown location

Patients will be approached for recruitment following PUL classification. Sample collection at time of classification +/- 48 hours later, timed for when bloods are taken as part of routine clinical practice +/- at any time patient attends for clinically indicated blood samples.

Sample collection

Intervention Type OTHER

Bloods +/- urine +/- vaginal swabs taken

Ectopic Pregnancy

Patients will be approached for recruitment following Ectopic Pregnancy diagnosis. Ectopic pregnancies that are recruited as PUL do not need to be re-approached as they are already part of the study. Sample collection at time of diagnosis when bloods are taken as part of routine clinical practice +/- at any time patient attends for clinically indicated blood samples.

Sample collection

Intervention Type OTHER

Bloods +/- urine +/- vaginal swabs taken

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sample collection

Bloods +/- urine +/- vaginal swabs taken

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes