Effect of a Structured Postnatal Debriefing on Psychological Outcomes and Birth Experience in Women After Adverse or Unexpected Obstetric Events
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 142
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Due to the nature of the intervention, blinding is not feasible.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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
干预措施: Structured Postnatal Debriefing (Behavioral)
结局指标
主要结局
未指定
次要结局
- Postpartum depressive symptoms measured by Edinburgh Postnatal Depression Scale (EPDS)(6 weeks postpartum)
研究者
Laura Martínez Verdú
Principal Investigator
Parc de Salut Mar