Psychological Impact of Pregnancy of Unknown Location

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Brief Title

Psychological Impact of Pregnancy of Unknown Location

Official Title

Psychological Impact of Pregnancy of Unknown Location

Brief Summary

      To assess the psychological impact of pregnancy of unknown location (PUL) classification
      pending a final diagnosis.

Detailed Description

      PUL is a syndrome of early pregnancy composed of a positive urine pregnancy test without the
      visualisation of a pregnancy on trans-vaginal ultrasound (TVUS). The current method for risk
      stratifying a PUL is via serum BhCG levels at the time of identification of PUL and after 48
      hours, in order to ascertain the viability of the pregnancy. Patients and their partners need
      to wait for this result before a management plan can be adopted, taking at least 2-3 hours.
      There is a clear need for the patient care pathway to evolve in order to aid and improve the
      management of women classified with a PUL. By using point-of-care BhCG testing, the
      investigators hope to shorten the time to management. The investigators therefore propose
      that shortening the time interval would reduce psychological morbidity. This is a prospective
      cohort observational study.

Study Type

Observational

Primary Outcome

Psychological morbidity

Condition

Pregnancy of Unknown Location

Intervention

The Hospital and Anxiety Depression Scale

Study Arms / Comparison Groups

 Patient: point of care (POC) result not shared
Description:  Patients in this phase of the study will not be provided with the POC BhCG result. They will await the laboratory result. Simultaneously we will ascertain reliability of POC in clinical practice during this time.

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

218

Start Date

December 2, 2020

Completion Date

September 30, 2022

Primary Completion Date

September 30, 2022

Eligibility Criteria

        Inclusion Criteria:

          -  Pregnant women attending the Early Pregnancy Unit in the first trimester (up to 14
             weeks gestation) with a pregnancy of unknown who are over 18 years old and are able to
             give consent.

        Exclusion Criteria:

          -  Presence diagnosed with cancer

          -  The presence of an acute medical condition

          -  Patients/partners aged less than 18 years

          -  Patients or partners who cannot give fully informed study consent (language or
             learning impairment)

          -  Presence of a viable intrauterine pregnancy, ectopic pregnancy and miscarriage.

Gender

Female

Ages

18 Years - 50 Years

Contacts

, 0044 203 313 5131, [email protected]

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations

NCT ID

NCT04739956

Organization ID

19QC5631

Responsible Party

Sponsor

Study Sponsor

Imperial College London

Collaborators

 Imperial College Healthcare NHS Trust

Study Sponsor

, ,

Verification Date

March 2022