Stress Disorders, Post-TraumaticDBIRTHNCT07579273
Postnatal Debriefing After Adverse Obstetric Events
A study testing Structured Postnatal Debriefing in people with Stress Disorders, Post-Traumatic and Psychological Trauma, run by Parc de Salut Mar.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stress Disorders, Post-Traumatic, Psychological Trauma, Obstetric Labor Complications
- What is being tested?
- Structured Postnatal Debriefing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Stress Disorders, Post-Traumatic, Psychological Trauma, Obstetric Labor Complications, Postpartum Period
- Being tested
- Structured Postnatal Debriefing, Usual Care
- Keywords
- Traumatic Birth, Birth Experience, Postpartum PTSD, Postnatal Debriefing, Obstetric Debriefing, Patient-Centered Care, Maternal Mental Health
- Medical subject headings
- Stress Disorders, Post-Traumatic, Psychological Trauma, Obstetric Labor Complications, Birth Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Postnatal DebriefingBehavioural
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.
Usual CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks postpartum
Secondary outcomes (4)
Birth satisfaction measured by Birth Satisfaction Scale-Revised (BSS-R)
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
Measured: 48-72 hours postpartum
Early post-traumatic stress symptoms measured by Impact of Event Scale-Revised (IES-R)
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.
Measured: 48-72 hours postpartum
Satisfaction with information and emotional support received after childbirth
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.
Measured: 48-72 hours postpartum
Postpartum depressive symptoms measured by Edinburgh Postnatal Depression Scale (EPDS)
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.
Measured: 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Martínez Verdú, Parc de Salut Mar
- Investigators
- Azucena Justicia Diaz, PhD, RN, Study director, Parc de Salut MarRamon Escuriet Peiro, Study director, Health Department in Catalonia, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07579273
- Sponsor's protocol ID
- DEBRIEF-BIRTH-01
- Acronym
- DBIRTH
- Status last verified
- Jun 2026
- First submitted
- 6 May 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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.
PubMed 25858181
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Structured Postnatal Debriefing on Psychological Outcomes and Birth Experience in Women After Adverse or Unexpected Obstetric Events
- ClinicalTrials.gov ID
- NCT07579273
- Acronym / sponsor ID
- DBIRTH / DEBRIEF-BIRTH-01
- Conditions
- Stress Disorders, Post-Traumatic, Psychological Trauma, Obstetric Labor Complications, Postpartum Period
- Keywords
- Traumatic Birth, Birth Experience, Postpartum PTSD, Postnatal Debriefing, Obstetric Debriefing, Patient-Centered Care, Maternal Mental Health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 12 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Postnatal Debriefing | Experimental | Behavioral: Structured Postnatal DebriefingParticipants 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 |
| Usual Postpartum Care | Active comparator | Other: Usual CareParticipants receive standard postpartum care, which may include a non-structured clinical explanation of events according to routine practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured Postnatal DebriefingA 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. | Behavioural | Postnatal Debriefing |
| Usual CareParticipants 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. | Other | Usual Postpartum Care |
Primary outcome
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- BackgroundMousavi 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: PubMed 25858181Bastos 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.
- Individual participant dataSharing planned: No. 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.
Related trials for Stress Disorders, Post-Traumatic
Recruiting
Early Intervention for Postpartum PTSD: Comparing Written Exposure and Capnometry-Guided Breathing Therapy
Written Exposure Therapy, Breathing Techniques
Not yet recruiting
RISE for PTSD and Substance Use Disorder in Veterans
Stress Disorders, Post-Traumatic, Substance-Related Disorders
Not yet recruiting
Multimodal Intervention for Individuals With Posttraumatic Stress Disorder (PTSD) and Hazardous Alcohol Use
Post Traumatic Stress Disorder PTSD, Hazardous Alcohol Use
Recruiting
Recovering Sleep After Trauma
Post-traumatic Stress Disorder
Not yet recruitingPhase 2
Written Exposure Therapy Plus Adjunctive Methylphenidate Treatment for Veterans With PTSD
PTSD - Post Traumatic Stress Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Azucena Justicia Diaz, PhD, RN study director
Parc de Salut Mar
Ramon Escuriet Peiro study director
Health Department in Catalonia, Spain
Questions about this trial
What is this clinical trial studying?
A study testing Structured Postnatal Debriefing in people with Stress Disorders, Post-Traumatic and Psychological Trauma, run by Parc de Salut Mar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Martínez Verdú, RN, MSc (+34696591393, lmartinezverdu@hmar.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Childbirth-related post-traumatic stress symptoms measured by City Birth Trauma Scale (City BiTS) (time frame: 6 weeks postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07579273, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.