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Postnatal Debriefing After Adverse Obstetric Events (DBIRTH)

2026年6月22日 更新者:Laura Martínez Verdú、Parc de Salut Mar

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.

研究概览

详细说明

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.

研究类型

介入性

注册 (估计的)

142

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名:Elena Ferriols Pérez, MD, PhD
  • 电话号码:+34605588984
  • 邮箱:eferriols@hmar.cat

研究联系人备份

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:非随机化
  • 介入模型:顺序分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的: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.
有源比较器: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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Childbirth-related post-traumatic stress symptoms measured by City Birth Trauma Scale (City BiTS)
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
Birth satisfaction measured by Birth Satisfaction Scale-Revised (BSS-R)
大体时间: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
Early post-traumatic stress symptoms measured by Impact of Event Scale-Revised (IES-R)
大体时间: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.
48-72 hours postpartum
Satisfaction with information and emotional support received after childbirth
大体时间: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)
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任:Azucena Justicia Diaz, PhD, RN、Parc de Salut Mar
  • 研究主任:Ramon Escuriet Peiro、Health Department in Catalonia, Spain

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年10月1日

初级完成 (估计的)

2028年12月1日

研究完成 (估计的)

2029年1月1日

研究注册日期

首次提交

2026年5月6日

首先提交符合 QC 标准的

2026年5月6日

首次发布 (实际的)

2026年5月12日

研究记录更新

最后更新发布 (实际的)

2026年6月25日

上次提交的符合 QC 标准的更新

2026年6月22日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

Individual participant data (IPD) will not be shared due to the sensitive nature of the data and to ensure participant confidentiality in accordance with applicable data protection regulations.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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