Postnatal Debriefing After Adverse Obstetric Events

Official title

Effect of a Structured Postnatal Debriefing on Psychological Outcomes and Birth Experience in Women After Adverse or Unexpected Obstetric Events

Overview

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.

Detailed description

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.

Interventions

• Behavioral Structured Postnatal Debriefing
  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.
• Other Usual Care
  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.

Primary outcome measures

• Childbirth-related post-traumatic stress symptoms measured by City Birth Trauma Scale (City BiTS) [Time frame: 6 weeks postpartum]

Secondary outcome measures (4)

• Birth satisfaction measured by Birth Satisfaction Scale-Revised (BSS-R) [Time frame: 48-72 hours postpartum]
• Early post-traumatic stress symptoms measured by Impact of Event Scale-Revised (IES-R) [Time frame: 48-72 hours postpartum]
• Satisfaction with information and emotional support received after childbirth [Time frame: 48-72 hours postpartum]
• Postpartum depressive symptoms measured by Edinburgh Postnatal Depression Scale (EPDS) [Time frame: 6 weeks postpartum]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Sequential

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• 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. PMID 25858181

Identifiers

NCT: NCT07579273 · DEBRIEF-BIRTH-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗