An interventional study of Structured Postnatal Debriefing and Usual Care in Stress Disorders, Post-Traumatic, Psychological Trauma and Obstetric Labor Complications, sponsored by Parc de Salut Mar. Not yet recruiting. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-25.
Sponsored by Parc de Salut Mar · Not applicable, Interventional, and Treatment
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.
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.
2,682 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 601 are open to participants now.
This study's planned enrollment of 142 is above the median of 69 across 2,196 interventional studies indexed under Stress Disorders, Post-Traumatic.
Browse Stress Disorders, Post-Traumatic studies →Parc de Salut Mar is the lead sponsor of 182 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Participants receive standard postpartum care, which may include a non-structured clinical explanation of events according to routine practice.
Other: Usual Care
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.
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.
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.
Time frame: 6 weeks postpartum
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 weeks postpartum
No study locations are listed for this record.
Plan to share: 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.
Start is estimated for Oct 2026; primary completion for Dec 2028, 26 months later.
Of 1,064 non-industry interventional studies with no phase under Stress Disorders, Post-Traumatic, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 53. This study's planned 26 months is below that.
Counting every sponsor, half of 1,092 studies reached it within 34 months; a quarter within 17 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Stress Disorders, Post-Traumatic →