Psychological Impact of Pregnancy of Un… | Clinical Trial

Key information

Conditions

Pregnancy of Unknown Location Anxiety Anxiety Disorders Ectopic Pregnancy Female Urogenital Diseases and Pregnancy Complications Mental Disorders Pregnancy Complications Pregnancy, Ectopic Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Imperial College Healthcare NHS Trust

London, W12 0HS, United Kingdom

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

The Hospital and Anxiety Depression Scale

Other

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)

Other

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).

Primary outcomes

Psychological Morbidity

Time frame: 0 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.

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

Imperial College Healthcare NHS Trust

Registry information

Acronym: SOUL

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2022
First posted: Feb 5, 2021
Registry last updated: Jan 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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