Psychological Impact of Pregnancy of Unknown Location (SOUL)

Imperial College London

Status: Completed

Conditions: Ectopic Pregnancy; Pregnancy of Unknown Location; Anxiety

Treatments: Other: Point of care testing (POCT); Other: The Hospital and Anxiety Depression Scale

Study type: Observational

Funder types: Other

Identifiers

NCT04739956

19QC5631

Details and patient eligibility

About

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

Full 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.

Enrollment: 150 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

150 participants in 2 patient groups

Patient: point of care (POC) result not shared

Description:

Patients in this phase of the study will not be provided with the POC BhCG result. They will await the laboratory result. Simultaneously we will ascertain reliability of POC in clinical practice during this time.

Treatment:

Other: The Hospital and Anxiety Depression Scale

Other: Point of care testing (POCT)

Patient: point of care (POC) result shared

Description:

Patients in this phase will be informed of the POC test result, which will reduce the time to which they receive the result. Prior to transfer to this phase, correlation between POC and laboratory BhCG levels will be calculated in order to confirm its reliability by creating a correlation curve using the data.

Treatment:

Other: The Hospital and Anxiety Depression Scale

Other: Point of care testing (POCT)