NCT04739956

Psychological Impact of Pregnancy of Unknown Location

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 150 (actual)
• Sponsor: Imperial College London · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: —

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.

Conditions

• Pregnancy of Unknown Location
• Ectopic Pregnancy
• Anxiety

Interventions

Type	Name	Description
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.
OTHER	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).

Timeline

• Start date: 2020-12-02
• Primary completion: 2022-03-31
• Completion: 2022-03-31
• First posted: 2021-02-05
• Last updated: 2025-01-15
• Results posted: 2025-01-15

Locations

1 site across 1 country: United Kingdom