- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07579273
Postnatal Debriefing After Adverse Obstetric Events (DBIRTH)
Effect of a Structured Postnatal Debriefing on Psychological Outcomes and Birth Experience in Women After Adverse or Unexpected Obstetric Events
Adverse or unexpected obstetric events can negatively affect women's psychological well-being and childbirth experience, increasing the risk of postpartum traumatic stress. However, structured postnatal debriefing is not routinely implemented in clinical practice, and evidence regarding its effectiveness remains limited.
This study aims to evaluate the effect of a structured postnatal debriefing conducted within the first 24 hours after childbirth in women who have experienced an adverse or unexpected obstetric event.
This quasi-experimental pretest-posttest study will include two consecutive groups: a control group receiving usual postpartum care during the pre-implementation phase and an intervention group receiving structured postnatal debriefing during the implementation phase.
The primary outcome is childbirth-related trauma at 6 weeks postpartum. Secondary outcomes include birth satisfaction, early post-traumatic stress symptoms, satisfaction with information and emotional support received after childbirth, and clinical maternal and neonatal outcomes.
This study will provide evidence on whether structured postnatal debriefing improves psychological outcomes and contributes to more patient-centered obstetric care.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This study is part of a mixed-methods research project evaluating the implementation of postnatal debriefing in obstetric care. The present phase consists of a prospective quasi-experimental pretest-posttest study with two consecutive groups.
The study will be conducted at the Department of Obstetrics and Gynecology of Parc de Salut Mar, Barcelona, Spain. Eligible participants are women who experience an adverse or unexpected obstetric event during labor or the immediate postpartum period and are clinically stable within the first 24 hours after childbirth.
Participants will be allocated to one of two consecutive groups according to the study implementation phase. Women included during the pre-implementation phase will receive usual postpartum care (control group), while women included during the implementation phase will receive a structured postnatal debriefing intervention in addition to usual care (intervention group).
The intervention consists of a structured, individualized postnatal debriefing session conducted within the first 24 hours postpartum by a senior obstetrician together with the midwife responsible for the woman's care. The session lasts approximately 15-30 minutes and follows a semi-structured guide including emotional assessment, active listening, clinical explanation of the event, validation of emotions, and opportunity for questions. The intervention is adapted to each woman's needs.
Data will be collected at hospital discharge (approximately 48-72 hours postpartum) and at 6 weeks postpartum using validated instruments through a secure electronic data capture system (REDCap).
The primary outcome is childbirth-related trauma assessed at 6 weeks postpartum using the City Birth Trauma Scale (City BiTS). Secondary outcomes include birth satisfaction assessed with the Birth Satisfaction Scale-Revised (BSS-R), early post-traumatic stress symptoms assessed with the Impact of Event Scale-Revised (IES-R), satisfaction with information and emotional support received after childbirth, and clinical maternal and neonatal outcomes.
The sample size has been calculated to detect clinically meaningful differences between groups, with a total of 142 participants (71 per group), accounting for potential losses to follow-up.
This study aims to generate evidence on the effectiveness and feasibility of structured postnatal debriefing as a patient-centered intervention to improve psychological recovery after adverse childbirth experiences.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Elena Ferriols Pérez, MD, PhD
- Número de teléfono: +34605588984
- Correo electrónico: eferriols@hmar.cat
Copia de seguridad de contactos de estudio
- Nombre: Laura Martínez Verdú, RN, MSc
- Número de teléfono: +34696591393
- Correo electrónico: lmartinezverdu@hmar.cat
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Women aged 18 years or older.
- Women who have experienced an adverse or unexpected obstetric event during labor or the immediate postpartum period.
- Admitted to the maternity unit of Hospital del Mar and clinically stable within the first 24 hours postpartum.
- Able to understand and communicate in Spanish, Catalan, or English.
- Willing to participate and able to provide written informed consent.
- Access to an email account for follow-up assessments.
Exclusion Criteria:
- Inability to communicate verbally.
- Maternal-neonatal separation due to social reasons.
- Unstable or severe psychiatric condition.
- Immediate perinatal loss (intrapartum fetal death or early neonatal death).
- Admission to intensive care within the first 24 hours postpartum.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Postnatal Debriefing
Participants receive a structured postnatal debriefing session conducted within the first 24 hours postpartum by a senior obstetrician together with the midwife responsible for the woman's care.
The session includes emotional assessment, active listening, clinical explanation of the obstetric event, validation of emotions, and opportunity for questions
|
A structured postnatal debriefing session conducted within the first 24 hours postpartum by a senior obstetrician and the midwife responsible for the woman's care.
The session takes place in the maternity ward room, in a private and supportive environment, and may include a companion chosen by the woman if she wishes.
The intervention includes a structured clinical explanation of events, emotional validation, and an opportunity for the woman to ask questions and express her experience.
|
|
Comparador activo: Usual Postpartum Care
Participants receive standard postpartum care, which may include a non-structured clinical explanation of events according to routine practice.
|
Participants receive routine postpartum care according to standard clinical practice.
This may include routine clinical follow-up and non-structured explanations regarding the obstetric event when considered necessary by healthcare professionals.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Childbirth-related post-traumatic stress symptoms measured by City Birth Trauma Scale (City BiTS)
Periodo de tiempo: 6 weeks postpartum
|
Post-traumatic stress symptoms related to childbirth will be assessed using the City Birth Trauma Scale (City BiTS), a validated questionnaire based on DSM-5 criteria for postpartum post-traumatic stress disorder.
The scale evaluates symptoms such as re-experiencing, avoidance, hyperarousal, and negative cognitions related to childbirth.
Scores range from 0 to 60, with higher scores indicating more severe childbirth-related post-traumatic stress symptoms.
|
6 weeks postpartum
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Birth satisfaction measured by Birth Satisfaction Scale-Revised (BSS-R)
Periodo de tiempo: 48-72 hours postpartum
|
Birth satisfaction will be assessed using the Birth Satisfaction Scale-Revised (BSS-R), a validated 10-item questionnaire evaluating women's perceptions of their childbirth experience, including quality of care, stress experienced during labor, and personal attributes such as control and empowerment.
Each item is scored on a 5-point Likert scale.
Total scores range from 0 to 40, with higher scores indicating greater birth satisfaction
|
48-72 hours postpartum
|
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Early post-traumatic stress symptoms measured by Impact of Event Scale-Revised (IES-R)
Periodo de tiempo: 48-72 hours postpartum
|
Early postpartum traumatic stress symptoms related to childbirth will be assessed using the Impact of Event Scale-Revised (IES-R), a validated 22-item questionnaire that evaluates intrusion, avoidance, and hyperarousal symptoms associated with traumatic events.
Items are scored on a 5-point Likert scale from 0 to 4. Total scores range from 0 to 88, with higher scores indicating greater post-traumatic stress symptom severity.
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48-72 hours postpartum
|
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Satisfaction with information and emotional support received after childbirth
Periodo de tiempo: 48-72 hours postpartum
|
Satisfaction with information and emotional support received after childbirth will be assessed using a structured 5-item Likert-type questionnaire specifically developed for this study.
The questionnaire evaluates clarity of information, opportunity to express concerns, emotional support, consideration of emotional wellbeing, and communication with healthcare professionals.
Scores range from 0 to 20, with higher scores indicating greater satisfaction with communication, information, and emotional support received after the obstetric event.
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48-72 hours postpartum
|
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Postpartum depressive symptoms measured by Edinburgh Postnatal Depression Scale (EPDS)
Periodo de tiempo: 6 weeks postpartum
|
Postpartum depressive symptoms will be assessed using the Edinburgh Postnatal Depression Scale (EPDS), a validated 10-item screening tool widely used to identify women at risk of postpartum depression.
Each item is scored from 0 to 3, yielding a total score ranging from 0 to 30.
Higher scores indicate more severe depressive symptoms.
Scores of 10 or higher suggest clinically relevant depressive symptoms, while scores of 13 or higher indicate a high probability of depressive disorder.
|
6 weeks postpartum
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Azucena Justicia Diaz, PhD, RN, Parc de Salut Mar
- Director de estudio: Ramon Escuriet Peiro, Health Department in Catalonia, Spain
Publicaciones y enlaces útiles
Publicaciones Generales
- Mousavi S, Nourizadeh R, Babapour J, Hakimi S, Mokhtari F. Investigating the Effect of Debriefing Intervention on Postpartum Posttraumatic Stress Disorder. Int J Womens Health Reprod Sci. 2024;12(1):42-47.
- Bastos MH, Furuta M, Small R, McKenzie-McHarg K, Bick D. Debriefing interventions for the prevention of psychological trauma in women following childbirth. Cochrane Database Syst Rev. 2015 Apr 10;2015(4):CD007194. doi: 10.1002/14651858.CD007194.pub2.
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
Palabras clave
Términos MeSH relevantes adicionales
- Trastornos relacionados con el trauma y el estrés
- Enfermedades urogenitales
- Desordenes mentales
- Heridas y Lesiones
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Complicaciones del embarazo
- Infantil, Recién Nacido, Enfermedades
- Trastornos de Estrés, Traumáticos
- Enfermedades y anomalías congénitas, hereditarias y neonatales
- Trauma psicólogico
- Trastornos de estrés postraumático
- Complicaciones obstétricas del parto
- Lesiones de nacimiento
Otros números de identificación del estudio
- DEBRIEF-BIRTH-01
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
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