Postnatal Debriefing After Adverse Obstetric Events

NCT07579273 | Not Yet Recruiting

• 1 other identifier: DEBRIEF-BIRTH-01
• Study Type: interventional
• Target: 142
• Locations: 0 countries
• Sites: N/A

Brief Summary

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 randomized controlled trial 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. Participants will be randomly assigned to either an intervention group receiving structured debriefing or a control group receiving usual postpartum care. The primary outcome is childbirth-related trauma at 6 weeks postpartum. Secondary outcomes include birth satisfaction, early post-traumatic stress symptoms, 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

Conditions

Postpartum Period; Obstetric Labor Complications; Stress Disorders, Post-Traumatic; Psychological Trauma

Keywords

Traumatic Birth; Birth Experience; Postpartum PTSD; Postnatal Debriefing; Obstetric Debriefing; Patient-Centered Care; Maternal Mental Health

Outcome Measures

Primary Outcomes (1)

• Childbirth-related post-traumatic stress symptoms measured by City Birth Trauma Scale (City BiTS)

  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

Secondary Outcomes (4)

• Birth satisfaction measured by Birth Satisfaction Scale-Revised (BSS-R)

  48-72 hours postpartum

• Early post-traumatic stress symptoms measured by Impact of Event Scale-Revised (IES-R)

  48-72 hours postpartum

• Satisfaction with information and emotional support received after childbirth

  48-72 hours postpartum

• Postpartum depressive symptoms measured by Edinburgh Postnatal Depression Scale (EPDS)

  6 weeks postpartum

Study Arms (2)

Postnatal Debriefing

EXPERIMENTAL

Participants receive 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.

Behavioral: Structured Postnatal Debriefing

Usual Postpartum Care

NO INTERVENTION

Participants receive standard postpartum care, which may include a non-structured clinical explanation of events according to routine practice.

Interventions

Structured Postnatal Debriefing BEHAVIORAL

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.

Postnatal Debriefing

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Parc de Salut Mar: lead

Related Publications (2)

• 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.

  BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Psychological Trauma; Obstetric Labor Complications; Birth Injuries

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Wounds and Injuries

Study Officials

• Azucena Justicia Diaz, PhD, RN

  Parc de Salut Mar

  STUDY DIRECTOR

• Ramon Escuriet Peiro

  Health Department in Catalonia, Spain

  STUDY DIRECTOR

Central Study Contacts

Laura Martínez Verdú, RN, MSc

CONTACT

+34696591393; lmartinezverdu@hmar.cat

Elena Ferriols Pérez, MD, PhD

CONTACT

+34605588984; eferriols@hmar.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the intervention, participants and healthcare providers cannot be blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a two-arm, parallel-group randomized controlled trial with 1:1 allocation to intervention and control groups.

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 12, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share