Early Pregnancy Bleeding
Conditions
Brief summary
Patients Under 12 Weeks Pregnant With a Single Ongoing Pregnancy Attending the EPU Will be Randomly Assigned to Receive Their Personalised Miscarriage Risk Score or Not. The Study Explores Whether Sharing This Score Affects Anxiety and Whether Patients Find the Information Helpful and Acceptable. (PEMPS)
Detailed description
The PEMPS study is a prospective, randomised controlled investigation designed to evaluate the psychological impact of providing individualised miscarriage risk estimates to patients in early pregnancy. The study population comprises individuals attending an Early Pregnancy Unit (EPU) with a confirmed single ongoing intrauterine pregnancy under 12 weeks' gestation. Participants will be randomly allocated in a 1:1 ratio to either receive their personalised miscarriage risk score (intervention group) or to receive standard care without disclosure of such a score (control group). Randomisation will be implemented using a computer-generated allocation sequence with appropriate allocation concealment to minimize selection bias. The personalised miscarriage risk score will be derived using a validated predictive model incorporating relevant clinical and ultrasound parameters routinely collected during EPU assessment. The methodology underlying the risk calculation will remain consistent across participants to ensure comparability and reproducibility. Participants in the intervention arm will be provided with their individualised risk estimate in a standardised format, accompanied by a brief explanation to support interpretation. Care will be taken to ensure that the communication approach is clear, non-directive, and does not include additional counselling beyond standard clinical practice. Participants in the control arm will receive routine clinical information and follow-up as per standard EPU protocols, without access to the calculated risk score. The primary objective of the study is to determine whether disclosure of a personalised miscarriage risk score influences patient-reported anxiety levels in early pregnancy, assessed using a validated questionnaires on Day 0 and Day 7. The secondary objective is patient acceptability of the study using qualitative feedback on Day 7.
Interventions
OTHERWill not receive miscarriage prediction score
These patients will not receive a miscarriage prediction score
OTHERMiscarriage prediction score
Half of the patients will receive a uniquely calculated miscarriage prediction score based on symptoms and individual characteristics
Sponsors
King's College Hospital NHS Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have capacity to understand the study and to provide signed and dated informed consent. * Willing to comply with all study procedures and be available for the duration of the study including consenting to follow up of the pregnancy outcome by letter, phone or email according to individual preference. * Age 16 years or over * Single live ongoing intrauterine pregnancy less than 12 weeks gestation
Exclusion criteria
Women with pregnancies of unknown location, ectopic pregnancies or early pregnancy prior to an embryo being seen or an embryo without a heartbeat. * Multiple pregnancies * Those undergoing assessment or treatment for a psychological condition by a psychiatrist * Those who do not speak English or require a translator * Women who have taken part in another clinical trial in the last 3 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To measure the psychological effects of the miscarriage prediction model | 7 days | The study will measure patients' psychological wellbeing objectively using a composite psychological distress score. This composite score is derived by combining the Hospital Anxiety and Depression Scale (HADS) and Penn State Worry Questionnaire (PSWQ) scores. The HADS score has a minimum score of 0 (Low Anxiety/Depression) and maximum score of 42 (High Anxiety/Depression). The PSWQ has a minimum score of 16 (Low Worry) and a maximum score of 80 (High Worry). The composite score will therefore have a minimum score of 16 (low psychological distress) and a maximum score of 122 (greater psychological distress). These questionnaires will be completed on day 0 and day 7 by patients in both treatment arms and a composite score will be calculated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of receiving miscarriage prediction score | 7 days | Acceptability will be assessed by sending patients who receive a miscarriage prediction score the following questions: 1. Did receiving the miscarriage prediction score help you feel more informed and prepared about your pregnancy outcome? (Yes/No, with an optional text box for further explanation.) 2. Would you recommend that other women in early pregnancy receive a miscarriage prediction score as part of their care? (Yes/No, with an optional explanation.) |
Contacts
CONTACTEleanor Fleming, MBBS BSc MRCOG
CONTACTJackie Ross
PRINCIPAL_INVESTIGATORJackie Ross, FRCOG
King's College Hospital NHS Trust
Outcome results
None listed