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Psychological Impact of Pregnancy of Unknown Location

Completed
Conditions
Ectopic Pregnancy
Anxiety
Pregnancy of Unknown Location
Registration Number
NCT04739956
Lead Sponsor
Imperial College London
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
150
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.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Psychological Morbidity0 hours, 48 hours and point of diagnosis (within 2 wees)

Psychological morbidity will be assessed using the Hospital Anxiety and Depression Scale on time of PUL classification, 48 hours from PUL classification and following final diagnosis and management. For both Anxiety and Depression, participants can score anywhere from 0 to 21. Score of 11 and above indicate moderate to severe anxiety and depression.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Imperial College Healthcare NHS Trust

🇬🇧

London, United Kingdom

Imperial College Healthcare NHS Trust
🇬🇧London, United Kingdom

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