Postnatal Debriefing After Adverse Obstetric Events (DBIRTH)
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
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Elena Ferriols Pérez, MD, PhD
- 전화번호: +34605588984
- 이메일: eferriols@hmar.cat
연구 연락처 백업
- 이름: Laura Martínez Verdú, RN, MSc
- 전화번호: +34696591393
- 이메일: lmartinezverdu@hmar.cat
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
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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.
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간섭 없음: Usual Postpartum Care
Participants receive standard postpartum care, which may include a non-structured clinical explanation of events according to routine practice.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Childbirth-related post-traumatic stress symptoms measured by City Birth Trauma Scale (City BiTS)
기간: 6 weeks postpartum
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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.
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6 weeks postpartum
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Postpartum depressive symptoms measured by Edinburgh Postnatal Depression Scale (EPDS)
기간: 6 weeks postpartum
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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.
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6 weeks postpartum
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Birth satisfaction measured by Birth Satisfaction Scale-Revised (BSS-R)
기간: 48-72 hours postpartum
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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
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48-72 hours postpartum
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Early post-traumatic stress symptoms measured by Impact of Event Scale-Revised (IES-R)
기간: 48-72 hours postpartum
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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.
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48-72 hours postpartum
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Satisfaction with information and emotional support received after childbirth
기간: 48-72 hours postpartum
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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.
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48-72 hours postpartum
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공동 작업자 및 조사자
수사관
- 연구 책임자: Azucena Justicia Diaz, PhD, RN, Parc de Salut Mar
- 연구 책임자: Ramon Escuriet Peiro, Health Department in Catalonia, Spain
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- DEBRIEF-BIRTH-01
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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Structured Postnatal Debriefing에 대한 임상 시험
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