Psychological Impact of Pregnancy of Unknown Location (SOUL)

Brief Summary To assess the psychological impact of pregnancy of unknown location (PUL) classification pending a final diagnosis.
Detailed Description
Purpose and design-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, we would shorten the time to management. We propose that shortening the time interval would reduce psychological morbidity. Prospective cohort observational study.

Recruitment-124 patients, 94 partners. Inclusion: 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. Their partners if present. Exclusion: 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.

Consent – Posters will advertise the study. Patients and partners in EPU will be invited to the study by a member of the clinical care team. Written consent will be required for the study.

Confidentiality – The Chief Investigator will preserve the confidentiality of participants taking part in the study and is registered under the Data Protection Act. Patient consent forms will be stored securely within the study file. All patient identifiable information, where required, will be stored electronically on National Health Service (NHS) approved computers, accessible only by personnel involved in the study via password.

Conflict of interest – None involved in the study have a conflict of interest. Dissemination of results – No patient identifiable information will be included in the research report or publication. Anonymised results will be disseminated to scientific community by means of publication in peer-reviewed literature and presented at national and international meetings.

Study Type Observational

Sampling Method Probability Sample
Study Population 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.
Condition
Pregnancy of Unknown Location
Ectopic Pregnancy
Anxiety
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.
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).
Study Groups/Cohorts
Patient: point of care (POC) result not shared
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.
Interventions:
Other: The Hospital and Anxiety Depression Scale
Other: Point of care testing (POCT)
Partner: point of care (POC) result not shared
Partners in this phase of the study will not be informed of the POC BhCG result. They will await the laboratory result to be provided to the patient. Simultaneously we will ascertain reliability of POC in clinical practice during this time.
Interventions:
Other: The Hospital and Anxiety Depression Scale
Other: Point of care testing (POCT)
Patient: point of care (POC) result shared
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.
Interventions:
Other: The Hospital and Anxiety Depression Scale
Other: Point of care testing (POCT)
Partner: point of care (POC) result shared
Partners in this phase will be informed of the POC test result with the patient, 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.
Interventions:
Other: The Hospital and Anxiety Depression Scale
Other: Point of care testing (POCT)

Contact: Tom Bourne, MBBS, PhD, MRCOG 0044 203 313 5131 t.bourne@ic.ac.uk
Contact: Christopher Kyriacou, MBBS, BSc 0044 203 313 5131 Christopher.kyriacou@nhs.net