Assessment of Biomarkers in Pregnancy on Unknown Location and Ectopic Pregnancy

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Brief Title

Assessment of Biomarkers in Pregnancy on Unknown Location and Ectopic Pregnancy

Official Title

Assessment of Biomarkers in Pregnancy on Unknown Location and Ectopic Pregnancy

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.
    


Study Type

Observational


Primary Outcome

PUL outcome prediction

Secondary Outcome

 Urinary BhCG and PUL

Condition

Pregnancy of Unknown Location

Intervention

Sample collection

Study Arms / Comparison Groups

 Pregnancy of unknown location
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

1000

Start Date

December 8, 2014

Completion Date

December 31, 2024

Primary Completion Date

December 31, 2024

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
      

Gender

Female

Ages

18 Years - 50 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, 0044 203 313 5131, [email protected]

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations


NCT ID

NCT04738370

Organization ID

14HH2202


Responsible Party

Sponsor

Study Sponsor

Imperial College London

Collaborators

 Imperial College Healthcare NHS Trust

Study Sponsor

, , 


Verification Date

March 2022