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)
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
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.
Parallel
Miscarriage prediction score
Other interventionHalf of the patients will receive a uniquely calculated miscarriage prediction score based on symptoms and individual characteristics
Will not receive miscarriage prediction score
Other interventionThese patients will not receive a miscarriage prediction score
To measure the psychological effects of the miscarriage prediction model
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.
To measure the psychological effects of the miscarriage prediction model
The study will measure patients' psychological wellbeing objectively using the Penn State Worry Questionnaire (PSWQ) score. The Penn State Worry Questionnaire has a minimum score of 16 (Low Worry) and a maximum score of 80 (High Worry). This questionnaire will be completed on day 0 and day 7 by patients in both treatment arms.
Acceptability of receiving miscarriage prediction score
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.)
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This trial is not recruiting at the moment. You can still explore other options:
