Psychological Impact of Pregnancy of Unknown Location (SOUL)

• Research type

  Research Study

• Full title

  Psychology of pregnancy of unknown location (SOUL)

• IRAS ID

  254910

• Contact name

  Tom Bourne

• Contact email

  t.bourne@imperial.ac.uk

• Sponsor organisation

  Imperial College London

• Clinicaltrials.gov Identifier

  NCT04739956

• Duration of Study in the UK

  1 years, 0 months, 1 days

• Research summary

  Design
  Prospective cohort observational study

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

  Secondary aims
  To assess psychological burden of PUL on patients and their partners.
  To assess if shortening time to providing patients classified with PUL with results and advice using point-of-care beta human chorionic gonadotrophin (BhCG) testing reduces psychological burden.

  Hypothesis
  1) PUL causes significant psychological distress to patients and their partners which can be assessed using a validated psychological tool.
  2) Increasing the efficiency of PUL management will reduce anxiety and depression symptoms in patients and their partners.

  Outcome measures
  Psychological morbidity will be assessed using the HADS on time of PUL classification, 48 hours from PUL classification and following final diagnosis and management.

  Eligibility
  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.

  Duration
  The study will be conducted over a minimum period of one year.

• REC name

  London - Queen Square Research Ethics Committee

• REC reference

  20/LO/0477

• Date of REC Opinion

  23 Jul 2020

• REC opinion

  Further Information Favourable Opinion