NCT07579273

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 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P75+ for not_applicable

Timeline
27mo left

Started Oct 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 12, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2026

Expected
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

June 25, 2026

Status Verified

June 1, 2026

Enrollment Period

2.2 years

First QC Date

May 6, 2026

Last Update Submit

June 22, 2026

Conditions

Keywords

Traumatic BirthBirth ExperiencePostpartum PTSDPostnatal DebriefingObstetric DebriefingPatient-Centered CareMaternal 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 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

Behavioral: Structured Postnatal Debriefing

Usual Postpartum Care

ACTIVE COMPARATOR

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

Other: Usual Care

Interventions

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

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.

Usual Postpartum Care

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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: 25858181BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticPsychological TraumaObstetric Labor ComplicationsBirth Injuries

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesWounds 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

Elena Ferriols Pérez, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
Due to the nature of the intervention, blinding is not feasible.
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Participants will be enrolled into two consecutive study phases. During the pre-implementation phase, participants will receive usual postpartum care (control group). During the implementation phase, participants will receive structured postnatal debriefing in addition to usual care (intervention group).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

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

June 25, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

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.