Midwife-led Childbirth Review and Psychological Outcomes in New Parents (CROWN)
Effects of a Midwife-led Childbirth Review on Psychological Outcomes in New Parents
研究概览
详细说明
Childbirth is a profound experience that may have long-term effects on maternal mental health and psychosocial functioning. While a positive childbirth experience may enhance psychological well-being, a negative childbirth experience has been associated with an increased risk of postpartum mental health difficulties, including post-traumatic stress disorder and postpartum depression.
In maternity care settings, a frequently used intervention aimed at processing childbirth experience is postpartum debriefing, which provides mothers with an opportunity to discuss their birth experience with a healthcare professional, most commonly a midwife. Postpartum debriefing provided by midwives has been integrated into maternity care in some countries and is offered as a targeted intervention to women after traumatic childbirth to reduce postpartum psychological morbidity. In some settings, however, postpartum debriefing is offered universally to all postpartum women; this is in line with qualitative studies showing that most women appreciate midwives initiating discussions about childbirth, listening to their experiences with empathy and support, and providing them with relevant information.
Reviewing childbirth experience with a supportive healthcare professional may help women facilitate understanding and integration of this emotionally and physically demanding event while gaining a sense of closure. Consequently, postpartum debriefing with a midwife may not only reduce the risk of psychiatric problems in women with traumatic childbirth experiences but may also be beneficial for the general population of postpartum women as a supportive intervention promoting psychological adjustment after childbirth. Following Sheen and Slade (2015), we refer to this type of supportive intervention as "childbirth review" to distinguish it from psychological debriefing provided following an adverse event.
Although postpartum debriefing is widely used in maternity care settings and recommended by policymakers, evidence regarding its effectiveness in improving postpartum mental health remains inconsistent and of limited quality. In addition, studies focusing on outcomes such as postpartum anxiety, parenting competence, sleep, social relationships, or future reproductive choices are lacking. Moreover, previous research has focused primarily on postpartum mothers, while largely omitting fathers present at childbirth.
This study aims to address these gaps by evaluating the effectiveness of midwife-led childbirth review (MLCR) offered to all postpartum women, as well as their partners present at childbirth, in order to improve postpartum psychological outcomes. MLCR employed in this study is based on the counselling model developed by Gamble and Creedy (2009) to support women with traumatic births and adapted for the general population of parents in the postpartum period. In this study, MLCR is conceptualized as a supportive discussion about childbirth experience intended to facilitate its understanding and processing in new parents.
MLCR will be delivered by midwives in a structured 45-60-minute session and will include review of the childbirth experience, active listening, emotional support, clarification of childbirth-related events and procedures when needed, and provision of information related to the birth. Mothers and fathers/partners will receive MLCR separately. To ensure intervention consistency, all participating midwives will complete standardized training and receive a detailed intervention manual before study initiation. Supervision procedures and an intervention fidelity plan will be implemented throughout the study. Standard postpartum care will not include the structured MLCR procedure or predefined intervention elements.
Participants (pregnant women and their partners) will be recruited during the third trimester of pregnancy from Bulovka University Hospital in Prague and University Hospital Brno. Data will be collected during late pregnancy, within the first postpartum week, at 6-8 weeks postpartum, and at 6 months postpartum.
Following childbirth and confirmation of study eligibility, women will be randomized to one of four groups: (1) MLCR within the first postpartum week, (2) MLCR at 6-8 weeks postpartum, (3) MLCR at both time points, or (4) standard postpartum care. Randomization will be stratified by key obstetric and psychological characteristics (parity, mode of birth, childbirth experience, psychiatric history). Fathers/partners will be assigned to the same study group as the mother.
The primary outcomes are maternal symptoms of postpartum depression and perinatal anxiety. The primary hypothesis is that mothers receiving any form of MLCR will report lower levels of symptoms of postpartum depression and perinatal anxiety at 6 months postpartum than mothers receiving standard postpartum care. In addition, repeated MLCR will be more effective than single-session MLCR, and early-only and later-only MLCR will differ in their effects on maternal postpartum depression and perinatal anxiety symptoms at 6 months postpartum. At 6-8 weeks postpartum, mothers who received MLCR within the first postpartum week are expected to report lower levels of depressive and anxiety symptoms than mothers who had not yet received MLCR. We will also examine whether baseline depressive and anxiety symptoms during pregnancy moderate the effects of MLCR on postpartum psychological outcomes.
Secondary outcomes for mothers include symptoms of general anxiety, parenting sense of competence, mother-infant bonding, sleep, relationship satisfaction, perceived stress, birth experience, childbirth-related post-traumatic stress symptoms, observed mother-infant interaction quality, and future reproductive choices. Hypotheses tested for secondary outcomes in mothers correspond to those for the primary outcomes.
Data from fathers will be analyzed separately as secondary analyses, as we expect a substantially smaller sample size for fathers. Outcomes/hypotheses related to paternal data will parallel those for maternal data.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Michal Zikan, MD, PhD
- 电话号码:+420266083229
- 邮箱:michal.zikan@bulovka.cz
学习地点
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Brno、捷克语、60200
- University Hospital Brno
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接触:
- Andrea Mensikova, PhD, MHM
- 电话号码:+420 532 236 853
- 邮箱:mensikova.andrea@fnbrno.cz
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接触:
- Miloslava Kamenikova, Dr
- 电话号码:+420 532 238 443
- 邮箱:kamenikova.miloslava@fnbrno.cz
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首席研究员:
- Andrea Mensikova, PhD, MHM
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副研究员:
- Miloslava Kamenikova, Dr
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Prague、捷克语、18100
- Bulovka University Hospital
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接触:
- Michal Zikan, MD, PhD
- 电话号码:+420266083229
- 邮箱:michal.zikan@bulovka.cz
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接触:
- Vera Stepanova
- 电话号码:+420266083201
- 邮箱:vera.stepanova@bulovka.cz
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首席研究员:
- Michal Zikan, MD, PhD
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副研究员:
- Milada Baresova
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
Pregnant women: Age ≥ 18 years; Singleton pregnancy; Fluency in Czech; Women can enter the study without a partner; Live birth after enrollment. Partners: Partner of an enrolled woman; Age ≥ 18 years; Planning on being present at childbirth; Fluency in Czech
Exclusion Criteria:
Pregnant women: Age < 18 years; Multi-fetal pregnancy; Not being able to read and speak fluent Czech; A severe medical condition including significant pregnancy complications preventing participation in the intervention or assessments; Stillbirth or neonatal death; Infant admitted to intensive care for a prolonged or life-threatening condition; Acute psychiatric condition (suicidality, psychosis, manic episode, substance abuse). Partners: Age < 18 years; Not being able to read and speak fluent Czech; Not planning on being present at childbirth / after recruitment: not present at childbirth; A severe medical condition preventing participation in the intervention or assessments; Stillbirth or neonatal death; Infant admitted to intensive care for a prolonged or life-threatening condition; Acute psychiatric condition (suicidality, psychosis, manic episode, substance abuse)
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Experimental group A
MLCR within the first postpartum week.
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MLCR is a structured 45-60 min session that includes review of childbirth experience, active listening, emotional support, clarification of childbirth-related events and procedures when needed, and provision of information related to the birth.
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实验性的:Experimental group B
MLCR at 6-8 weeks postpartum
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MLCR is a structured 45-60 min session that includes review of childbirth experience, active listening, emotional support, clarification of childbirth-related events and procedures when needed, and provision of information related to the birth.
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实验性的:Experimental group C
MLCR both within the first postpartum week and at 6-8 weeks postpartum
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MLCR is a structured 45-60 min session that includes review of childbirth experience, active listening, emotional support, clarification of childbirth-related events and procedures when needed, and provision of information related to the birth.
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无干预:Control group (group D)
Standard postpartum care.
This care may include routine clinical communication with healthcare professionals but will not include the structured 45-60 min MLCR intervention or predefined MLCR elements.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Depressive symptoms measured via the Edinburgh Postnatal Depression Scale (EPDS)
大体时间:Baseline (third trimester of pregnancy), 6-8 weeks postpartum, 6 months postpartum
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EPDS is a 10-item self-report questionnaire to screen for postpartum depression but has also been validated for the use in pregnant women.
The score may range from 0 to 30, with higher scores indicating higher levels of depressive symptoms.
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Baseline (third trimester of pregnancy), 6-8 weeks postpartum, 6 months postpartum
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Perinatal anxiety symptoms measured via the Perinatal Anxiety Screening Scale (PASS)
大体时间:Baseline (third trimester of pregnancy), 6-8 weeks postpartum, 6 months postpartum
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PASS is a 31-item self-report questionnaire developed to screen for a broad range of anxiety symptoms during pregnancy and the postpartum period.
It consists of four subscales: Acute Anxiety and Adjustment; General Worry and Specific Fears; Perfectionism, Control and Trauma; Social Anxiety.
The score may range from 0 to 93, with higher scores indicating more severe anxiety.
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Baseline (third trimester of pregnancy), 6-8 weeks postpartum, 6 months postpartum
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Anxiety symptoms measured via the State-Trait Anxiety Inventory - state - short 5-item version (STAIS-5)
大体时间:Baseline (third trimester of pregnancy), within the first postpartum week, 6-8 weeks postpartum, 6 months postpartum
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STAIS-5 is a 5-item self-report questionnaire assessing state anxiety, i.e. how the person felt at the moment.
The score may range from 5 to 20, with higher scores indicating higher levels of state anxiety.
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Baseline (third trimester of pregnancy), within the first postpartum week, 6-8 weeks postpartum, 6 months postpartum
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Anxiety symptoms measured via the Generalized Anxiety Disorder Scale (GAD-7)
大体时间:Baseline (third trimester of pregnancy), 6-8 weeks postpartum, 6 months postpartum
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GAD-7 is a 7-item scale measuring worry and anxiety symptoms.
The score may range from 0 to 21, with higher scores indicating greater anxiety severity.
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Baseline (third trimester of pregnancy), 6-8 weeks postpartum, 6 months postpartum
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Maternal parenting self-esteem measured via the Maternal Self-report Inventory (MSRI)
大体时间:Baseline (third trimester of pregnancy), 6-8 weeks postpartum, 6 months postpartum
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MSRI is a 26-item self-report questionnaire measuring maternal parenting self-esteem.
The score may range from 26 to 130, with higher scores indicating higher maternal self-esteem.
The version for pregnancy contains 12 items.
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Baseline (third trimester of pregnancy), 6-8 weeks postpartum, 6 months postpartum
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Parenting self-esteem measured via the Parenting Sense of Competence Scale (PSOC)
大体时间:6 months postpartum
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The PSOC is a 17-item self-report questionnaire assessing parenting self-esteem.
It consists of two subscales: Satisfaction and Efficacy.
The total score may range from 17 to 102, with higher scores indicating higher parenting self-esteem.
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6 months postpartum
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Maternal bonding to the infant measured via the Maternal Postnatal Attachment Scale (MPAS)
大体时间:6-8 weeks postpartum, 6 months postpartum
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MPAS is a 19-item self-report questionnaire measuring maternal emotional tie to her child.
MPAS has three subscales: Quality of attachment, Absence of hostility, Pleasure in interaction.
The total score may range from 19 to 95, with higher scores indicating better bonding.
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6-8 weeks postpartum, 6 months postpartum
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Paternal bonding to the infant measured via the Paternal Postnatal Attachment Scale (PPAS)
大体时间:6-8 weeks postpartum, 6 months postpartum
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PPAS is a 19-item self-report questionnaire measuring paternal emotional tie to his child.
PPAS has three subscales: Patience and tolerance, Pleasure in interaction, Affection and pride.
The total score may range from 19 to 95, with higher scores indicating greater bonding.
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6-8 weeks postpartum, 6 months postpartum
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Sleep quality measured via the Pittsburgh Sleep Quality Index
大体时间:Baseline (third trimester of pregnancy), 6-8 weeks postpartum, 6 months postpartum
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PSQI is a 19-item self-reported questionnaire that assesses sleep quality and disturbances.
It consists of 7 component scores: sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping medication, and daytime dysfunction.
The total score may range from 0 to 21, with higher scores indicating a poorer sleep quality.
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Baseline (third trimester of pregnancy), 6-8 weeks postpartum, 6 months postpartum
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Relationship satisfaction measured via the Relationship Assessment Scale (RAS)
大体时间:Baseline (third trimester of pregnancy), 6-8 weeks postpartum, 6 months postpartum
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RAS is a 7-item questionnaire measuring global relationship satisfaction.
The total score may range from 7 to 35, with higher scores indicating higher satisfaction.
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Baseline (third trimester of pregnancy), 6-8 weeks postpartum, 6 months postpartum
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Perceived stress measured via the Perceived Stress Scale (PSS)
大体时间:Baseline (third trimester of pregnancy), 6-8 weeks postpartum, 6 months postpartum
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PSS is a 10-item measure detecting how often respondents perceived their lives as stressful, unpredictable, uncontrollable, and overwhelming in the last two weeks.
The total score may range from 0 to 40, with higher scores indicating higher levels of perceived stress.
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Baseline (third trimester of pregnancy), 6-8 weeks postpartum, 6 months postpartum
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Birth experience measured via the Birth Experiences Questionnaire (BEQ)
大体时间:Within the first postpartum week, 6-8 weeks postpartum, 6 months postpartum
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BEQ is a 10-item measure designed to assess parents' subjective birth experience, including perceptions of stress, fear, pain, control, partner support, and overall evaluation of childbirth.
The total score may range from 10 to 70, with higher scores indicating more negative birth experience.
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Within the first postpartum week, 6-8 weeks postpartum, 6 months postpartum
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Childbirth-related post-traumatic stress symptoms measured via the City Birth Trauma Scale (CityBiTS)
大体时间:6-8 weeks postpartum, 6 months postpartum
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CityBiTS is a 29-item self-report questionnaire assessing post-traumatic stress symptoms following childbirth based on the DSM-5 criteria for PTSD.
The total score may range from 0 to 60, with higher scores indicating higher levels of post-traumatic stress symptoms.
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6-8 weeks postpartum, 6 months postpartum
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Mother-infant interaction quality observed during a free play, assessed via coding scheme developed by Gartstein et al. (2008, 2018)
大体时间:6 months postpartum
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The coding scheme developed by Gartstein et al. (2008, 2018) provides ratings for the following domains: maternal sensitivity/responsiveness; synchrony/reciprocity of the dyad; tempo of the interactions; intensity of exchange; emotional tone; and child versus parent directedness.
Each domain is rated on a 7-point Likert scale (from 1 to 7) with higher scores reflecting higher levels of the respective attribute.
Two composite scores can be created: Engagement and Stimulation.
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6 months postpartum
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Future reproductive choices assessed via the questionnaire items developed specifically for the purposes of this study.
大体时间:6 months postpartum
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Questions focusing on preferred mode of delivery in future childbirth, intention to have another child, and intention to postpone future pregnancy.
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6 months postpartum
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合作者和调查者
调查人员
- 研究主任:Lea Takacs, PhD、Masaryk University
- 首席研究员:Michal Zikan, MD, PhD、Bulovka University Hospital
出版物和有用的链接
一般刊物
- Sheen, K., & Slade, P. (2015). The efficacy of 'debriefing'after childbirth: is there a case for targeted intervention?. Journal of reproductive and infant psychology, 33(3), 308-320.
- Gamble J, Creedy DK. A counselling model for postpartum women after distressing birth experiences. Midwifery. 2009 Apr;25(2):e21-30. doi: 10.1016/j.midw.2007.04.004. Epub 2007 Jul 27.
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- AZV-NW25-09-00321
- NW25-09-00321 (其他赠款/资助编号:Czech Health Research Council)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
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