Psychological Impact of Pregnancy of Unknown Location

Completed

Conditions: Ectopic Pregnancy
Anxiety
Pregnancy of Unknown Location

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

Registration Number: NCT04739956

Lead Sponsor: Imperial College London

Brief 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 150

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.

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Partner: point of care (POC) result not shared	The Hospital and Anxiety Depression Scale	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.
Partner: point of care (POC) result not shared	Point of care testing (POCT)	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.
Patient: point of care (POC) result shared	The Hospital and Anxiety Depression Scale	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.
Partner: point of care (POC) result shared	The Hospital and Anxiety Depression Scale	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.
Patient: point of care (POC) result not shared	The Hospital and Anxiety Depression Scale	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.
Patient: point of care (POC) result not shared	Point of care testing (POCT)	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.
Patient: point of care (POC) result shared	Point of care testing (POCT)	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.
Partner: point of care (POC) result shared	Point of care testing (POCT)	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.

Primary Outcome Measures

Name	Time	Method
Psychological Morbidity	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.

Secondary Outcome Measures