Postnatal Debriefing After Adverse Obstetric Events (DBIRTH)

May 11, 2026 updated by: 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: A Randomized Controlled Trial

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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, randomized controlled trial with two parallel groups (1:1 allocation).

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 randomly assigned to either an intervention group receiving a structured postnatal debriefing or a control group receiving usual postpartum care. Randomization will be performed using a computer-generated sequence with allocation concealment through sealed opaque envelopes.

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 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. Secondary outcomes include birth satisfaction, early post-traumatic stress symptoms, and clinical maternal and neonatal variables.

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 of structured postnatal debriefing as a feasible, scalable, and patient-centered intervention to improve psychological recovery after adverse childbirth experiences.

Study Type

Interventional

Enrollment (Estimated)

142

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Elena Ferriols Pérez, MD, PhD
  • Phone Number: +34605588984
  • Email: eferriols@hmar.cat

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Postnatal Debriefing
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
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.
No Intervention: Usual Postpartum Care
Participants receive standard postpartum care, which may include a non-structured clinical explanation of events according to routine practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Childbirth-related post-traumatic stress symptoms measured by City Birth Trauma Scale (City BiTS)
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postpartum depressive symptoms measured by Edinburgh Postnatal Depression Scale (EPDS)
Time Frame: 6 weeks postpartum
Postpartum depressive symptoms will be assessed using the Edinburgh Postnatal Depression Scale (EPDS), a validated screening tool widely used to identify women at risk of postpartum depression.
6 weeks postpartum
Birth satisfaction measured by Birth Satisfaction Scale-Revised (BSS-R)
Time Frame: 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)
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Parc de Salut Mar

Investigators

  • Study Director: Azucena Justicia Diaz, PhD, RN, Parc de Salut Mar
  • Study Director: Ramon Escuriet Peiro, Health Department in Catalonia, Spain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

January 1, 2029

Study Registration Dates

First Submitted

May 6, 2026

First Submitted That Met QC Criteria

May 6, 2026

First Posted (Actual)

May 12, 2026

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DEBRIEF-BIRTH-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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