The Psychological Effects of Miscarriage Prediction Score: A Prospective Study (PEMPS)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Eleanor Fleming, MBBS BSc MRCOG
- Número de teléfono: +4420 3299 3168
- Correo electrónico: eleanor.fleming@nhs.net
Copia de seguridad de contactos de estudio
- Nombre: Jackie Ross
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Receive Miscarriage Prediction Score
These participants will receive their miscarriage prediction score
|
Half of the patients will receive a uniquely calculated miscarriage prediction score based on symptoms and individual characteristics
|
|
Experimental: Will Not Receive Miscarriage Prediction Score
These patients will not receive a Miscarriage Prediction Score
|
These patients will not receive a miscarriage prediction score
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
To measure the psychological effects of the miscarriage prediction model
Periodo de tiempo: 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. |
7 days
|
|
To measure the psychological effects of the miscarriage prediction model
Periodo de tiempo: 7 days
|
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.
|
7 days
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Acceptability of receiving miscarriage prediction score
Periodo de tiempo: 7 days
|
Acceptability will be assessed by sending patients who receive a miscarriage prediction score the following questions:
|
7 days
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jackie Ross, FRCOG, King's College Hospital NHS Trust
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 356805
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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