Psychological Impact of Pregnancy of Unknown Location

Anxiety Clinical Trial

— SOUL  

Official title:

Psychological Impact of Pregnancy of Unknown Location

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04739956
• Other study ID #: 19QC5631
• Status: Recruiting
• Start date: December 2, 2020
• Est. completion date: September 30, 2022

Study information

• Verified date: March 2022
• Source: Imperial College London
• Contact: Tom Bourne, MBBS, PhD, MRCOG
• Phone: 0044 203 313 5131
• Email: t.bourne[@]ic.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Recruiting
• Enrollment: 218
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Ectopic Pregnancy
• Pregnancy of Unknown Location
• Pregnancy, Ectopic

Intervention

Other:
• The Hospital and Anxiety Depression Scale
Patients and partners will be asked to complete the questionnaire at three time points: 1) On classification of PUL at time zero once blood is taken, 2) at the 48-hour time point after blood is taken (if 48 hour bloods are required for the patient); and 3) after definitive diagnosis and management.
• Point of care testing (POCT)
Patients will have 1ml sample of blood taken for POCT at two time points: 1) On classification of PUL at time zero at the same time as when routine blood samples taken; and 2) at the 48-hour time point at the same time as when routine blood samples are taken (if 48 hour bloods are required).

Locations

Country	Name	City	State
United Kingdom	Imperial College Healthcare NHS Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
Imperial College London	Imperial College Healthcare NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychological morbidity	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.	18 months