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| Name | Class |
|---|---|
| Imperial College Healthcare NHS Trust | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Hospital and Anxiety Depression Scale | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0 hours, 48 hours and point of diagnosis (within 2 wees) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial College Healthcare NHS Trust | London | W12 0HS | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37886834 | Derived | Kyriacou C, Yang W, Kapur S, Maheetharan S, Pikovsky M, Parker N, Barcroft J, Bobdiwala S, Sur S, Stalder C, Gould D, Ofili-Yebovi D, Day A, Unsworth N, Wilkes EH, Tan T, Bourne T. Ambulatory human chorionic gonadotrophin (hCG) testing: a verification of two hCG point of care devices. Clin Chem Lab Med. 2023 Oct 30;62(4):664-673. doi: 10.1515/cclm-2023-0703. Print 2024 Mar 25. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. 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). |
| FG001 | 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. 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. 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | 0 hours, 48 hours and point of diagnosis (within 2 wees) |
|
15 months
Serious and other [non-serious] adverse events were not observed on blood sample collection. The rest of the study was with quesionnaires only: there was no expectation of exposure to any risks after blood sample collection, as the remaining of the study involved only the completion of quesionnaires by the patients.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patient: Point of Care (POC) Result Not Shared | Serious and other [non-serious] adverse events were not collected or assessed as part of the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Margaret Pikovsky | Imperial College Healthcare NHS Trust | +447870276373 | m.pikovsky@nhs.net |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 12, 2021 | Sep 2, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011271 | Pregnancy, Ectopic |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000067716 | Point-of-Care Testing |
| ID | Term |
|---|---|
| D019095 | Point-of-Care Systems |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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|
| Point of care testing (POCT) | Other | 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). |
|
| BG001 | 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. 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. 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). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. 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. 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). |
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|
| 0 |
| 74 |
| 0 |
| 74 |
| 0 |
| 74 |
| EG001 | Patient: Point of Care (POC) Result Shared | Serious and other [non-serious] adverse events were not collected or assessed as part of the study. | 0 | 76 | 0 | 76 | 0 | 76 |
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