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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Elena Ferriols Pérez, MD, PhD
- Número de telefone: +34605588984
- E-mail: eferriols@hmar.cat
Estude backup de contato
- Nome: Laura Martínez Verdú, RN, MSc
- Número de telefone: +34696591393
- E-mail: lmartinezverdu@hmar.cat
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição sequencial
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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 Ativo: 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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Childbirth-related post-traumatic stress symptoms measured by City Birth Trauma Scale (City BiTS)
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Birth satisfaction measured by Birth Satisfaction Scale-Revised (BSS-R)
Prazo: 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)
Prazo: 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
|
|
Satisfaction with information and emotional support received after childbirth
Prazo: 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.
|
48-72 hours postpartum
|
|
Postpartum depressive symptoms measured by Edinburgh Postnatal Depression Scale (EPDS)
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Azucena Justicia Diaz, PhD, RN, Parc de Salut Mar
- Diretor de estudo: Ramon Escuriet Peiro, Health Department in Catalonia, Spain
Publicações e links úteis
Publicações Gerais
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Transtornos Relacionados a Traumas e Estressores
- Doenças urogenitais
- Transtornos Mentais, Desordem Mental
- Ferimentos e Lesões
- Doenças urogenitais femininas e complicações na gravidez
- Complicações na Gravidez
- Lactente, Recém Nascido, Doenças
- Transtornos de Estresse Traumático
- Doenças e Anormalidades Congênitas, Hereditárias e Neonatais
- Trauma psicológico
- Transtornos de Estresse Pós-Traumático
- Complicações do Trabalho de Parto Obstétrico
- Lesões de Nascimento
Outros números de identificação do estudo
- DEBRIEF-BIRTH-01
Plano para dados de participantes individuais (IPD)
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Descrição do plano IPD
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