Trial Outcomes & Findings for Psychological Impact of Pregnancy of Unknown Location (NCT NCT04739956)
NCT ID: NCT04739956
Last Updated: 2025-01-15
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
150 participants
Primary outcome timeframe
0 hours, 48 hours and point of diagnosis (within 2 wees)
Results posted on
2025-01-15
Participant Flow
Participant milestones
| Measure |
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).
|
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).
|
|---|---|---|
|
Overall Study
STARTED
|
74
|
76
|
|
Overall Study
COMPLETED
|
73
|
75
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
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).
|
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).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Psychological Impact of Pregnancy of Unknown Location
Baseline characteristics by cohort
| Measure |
Patient: Point of Care (POC) Result Not Shared
n=74 Participants
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).
|
Patient: Point of Care (POC) Result Shared
n=76 Participants
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).
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33 years
STANDARD_DEVIATION 5.1 • n=5 Participants
|
34 years
STANDARD_DEVIATION 6 • n=7 Participants
|
34 years
STANDARD_DEVIATION 5.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
74 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
150 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
47 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
74 participants
n=5 Participants
|
76 participants
n=7 Participants
|
150 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Patient: Point of Care (POC) Result Not Shared
n=73 Participants
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).
|
Patient: Point of Care (POC) Result Shared
n=75 Participants
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).
|
|---|---|---|
|
Psychological Morbidity
0hrs anxiety score
|
10 score on a scale
Standard Deviation 5
|
10 score on a scale
Standard Deviation 4
|
|
Psychological Morbidity
0hrs depression score
|
5 score on a scale
Standard Deviation 4
|
5 score on a scale
Standard Deviation 4
|
|
Psychological Morbidity
48hrs anxiety score
|
10 score on a scale
Standard Deviation 5
|
9 score on a scale
Standard Deviation 4
|
|
Psychological Morbidity
48hrs depression score
|
6 score on a scale
Standard Deviation 4
|
5 score on a scale
Standard Deviation 4
|
Adverse Events
Patient: Point of Care (POC) Result Not Shared
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Patient: Point of Care (POC) Result Shared
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Margaret Pikovsky
Imperial College Healthcare NHS Trust
Phone: +447870276373
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place