An observational study in Pregnancy of Unknown Location, Ectopic Pregnancy and Anxiety, sponsored by Imperial College London. Completed at 1 site in United Kingdom. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-01-15.
Sponsored by Imperial College London · Observational
To assess the psychological impact of pregnancy of unknown location (PUL) classification pending a final diagnosis.
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.
83 studies on the registry are indexed under Pregnancy, Ectopic; 21 are open to participants now.
This study's enrollment of 150 is close to the median of 150 across 39 observational studies indexed under Pregnancy, Ectopic.
Browse Pregnancy, Ectopic studies →Imperial College London is the lead sponsor of 843 studies on the registry; 180 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Other: The Hospital and Anxiety Depression Scale · Other: 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.
Other: The Hospital and Anxiety Depression Scale · Other: Point of care testing (POCT)
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.
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).
Psychological Morbidity
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.
Time frame: 0 hours, 48 hours and point of diagnosis (within 2 wees)
| Milestone | Patient: Point of Care (POC) Result Not Shared | Patient: Point of Care (POC) Result Shared |
|---|---|---|
| Started | 74 | 76 |
| Completed | 73 | 75 |
| Not completed | 1 | 1 |
| Withdrew: Withdrawal by subject | 1 | 1 |
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.
| score on a scale | Patient: Point of Care (POC) Result Not Shared | Patient: Point of Care (POC) Result Shared |
|---|---|---|
| 0hrs anxiety score | 10 ± 5 | 10 ± 4 |
| 0hrs depression score | 5 ± 4 | 5 ± 4 |
| 48hrs anxiety score | 10 ± 5 | 9 ± 4 |
| 48hrs depression score | 6 ± 4 | 5 ± 4 |
Collected over 15 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patient: Point of Care (POC) Result Not Shared | 0/74 (0%) | 0/74 (0%) | 0/74 (0%) |
| Patient: Point of Care (POC) Result Shared | 0/76 (0%) | 0/76 (0%) | 0/76 (0%) |
| Age, Continuous(years) | Patient: Point of Care (POC) Result Not Shared | Patient: Point of Care (POC) Result Shared | Total |
|---|---|---|---|
| Mean | 33 ± 5.1 | 34 ± 6 | 34 ± 5.5 |
| Sex: Female, Male(Participants) | Patient: Point of Care (POC) Result Not Shared | Patient: Point of Care (POC) Result Shared | Total |
|---|---|---|---|
| Female | 74 | 76 | 150 |
| Male | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Patient: Point of Care (POC) Result Not Shared | Patient: Point of Care (POC) Result Shared | Total |
|---|---|---|---|
| White | 47 | 44 | 91 |
| Black | 6 | 8 | 14 |
| Asian | 11 | 14 | 25 |
| Mixed | 0 | 3 | 3 |
| Other | 10 | 7 | 17 |
| Region of Enrollment(participants) | Patient: Point of Care (POC) Result Not Shared | Patient: Point of Care (POC) Result Shared | Total |
|---|---|---|---|
| United Kingdom | 74 | 76 | 150 |
PDFs hosted by the registry, ClinicalTrials.gov.
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