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Postnatal Debriefing After Adverse Obstetric Events (DBIRTH)

11. maj 2026 opdateret af: 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

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

142

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Elena Ferriols Pérez, MD, PhD
  • Telefonnummer: +34605588984
  • E-mail: eferriols@hmar.cat

Undersøgelse Kontakt Backup

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: 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.
Ingen indgriben: Usual Postpartum Care
Participants receive standard postpartum care, which may include a non-structured clinical explanation of events according to routine practice.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Childbirth-related post-traumatic stress symptoms measured by City Birth Trauma Scale (City BiTS)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Postpartum depressive symptoms measured by Edinburgh Postnatal Depression Scale (EPDS)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Parc de Salut Mar

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. oktober 2026

Primær færdiggørelse (Anslået)

1. december 2028

Studieafslutning (Anslået)

1. januar 2029

Datoer for studieregistrering

Først indsendt

6. maj 2026

Først indsendt, der opfyldte QC-kriterier

6. maj 2026

Først opslået (Faktiske)

12. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • DEBRIEF-BIRTH-01

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

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