Anxiety, Ectopic Pregnancy, Pregnancy of Unknown Location
Conditions
Keywords
Pregnancy of unknown location, PUL, Ectopic pregnancy, Anxiety
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.
Interventions
OTHERThe 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.
OTHERPoint 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).
Sponsors
Imperial College Healthcare NHS Trust
Imperial College London
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 74 |
| 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). | 76 |
| Total | 150 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Patient: Point of Care (POC) Result Not Shared | Patient: Point of Care (POC) Result Shared | Total |
|---|---|---|---|
| Age, Continuous | 33 years STANDARD_DEVIATION 5.1 | 34 years STANDARD_DEVIATION 6 | 34 years STANDARD_DEVIATION 5.5 |
| Race/Ethnicity, Customized Asian | 11 Participants | 14 Participants | 25 Participants |
| Race/Ethnicity, Customized Black | 6 Participants | 8 Participants | 14 Participants |
| Race/Ethnicity, Customized Mixed | 0 Participants | 3 Participants | 3 Participants |
| Race/Ethnicity, Customized Other | 10 Participants | 7 Participants | 17 Participants |
| Race/Ethnicity, Customized White | 47 Participants | 44 Participants | 91 Participants |
| Region of Enrollment United Kingdom | 74 participants | 76 participants | 150 participants |
| Sex: Female, Male Female | 74 Participants | 76 Participants | 150 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 74 | 0 / 76 |
| other Total, other adverse events | 0 / 74 | 0 / 76 |
| serious Total, serious adverse events | 0 / 74 | 0 / 76 |
Outcome results
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.
Time frame: 0 hours, 48 hours and point of diagnosis (within 2 wees)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patient: Point of Care (POC) Result Not Shared | Psychological Morbidity | 0hrs anxiety score | 10 score on a scale | Standard Deviation 5 |
| Patient: Point of Care (POC) Result Not Shared | Psychological Morbidity | 0hrs depression score | 5 score on a scale | Standard Deviation 4 |
| Patient: Point of Care (POC) Result Not Shared | Psychological Morbidity | 48hrs anxiety score | 10 score on a scale | Standard Deviation 5 |
| Patient: Point of Care (POC) Result Not Shared | Psychological Morbidity | 48hrs depression score | 6 score on a scale | Standard Deviation 4 |
| Patient: Point of Care (POC) Result Shared | Psychological Morbidity | 48hrs depression score | 5 score on a scale | Standard Deviation 4 |
| Patient: Point of Care (POC) Result Shared | Psychological Morbidity | 0hrs anxiety score | 10 score on a scale | Standard Deviation 4 |
| Patient: Point of Care (POC) Result Shared | Psychological Morbidity | 48hrs anxiety score | 9 score on a scale | Standard Deviation 4 |
| Patient: Point of Care (POC) Result Shared | Psychological Morbidity | 0hrs depression score | 5 score on a scale | Standard Deviation 4 |