Postnatal Debriefing After Adverse Obstetric Events

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorParc de Salut Mar

About this 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 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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.

  • Usual Care

    Other intervention

    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.

Treatment groups

142 Participants
are divided into 2 treatment groups
Group A: Postnatal DebriefingExperimental treatment 1 intervention
Group B: Usual Postpartum CareActive comparator 1 intervention

Trial outcomes

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.

Time frame
6 weeks postpartum

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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