Midwife-led Childbirth Review and Psychological Outcomes in New Parents (CROWN)

Effects of a Midwife-led Childbirth Review on Psychological Outcomes in New Parents

The aim of this clinical trial is to support psychological well-being and facilitate adjustment to parenthood among postpartum mothers and fathers through a midwife-led childbirth review (MLCR). MLCR is a structured 45-60-minute postpartum intervention focused on processing and integration of the individual's childbirth experience, involving active listening, emotional support, and provision of information. In this study, the investigators will employ the MLCR intervention developed by Gamble and Creedy (2009) for women with traumatic birth experiences, adapted for use in the general population of new parents, including both mothers and fathers/partners. This study will compare the effectiveness of three MLCR models - MLCR provided within the first postpartum week, MLCR provided at 6-8 weeks postpartum, and MLCR provided at both time points - with standard postpartum care and with each other.

Study Overview

• Status: Not yet recruiting
• Conditions: Perinatal Anxiety; Postpartum Depression (PPD); Postpartum Mental Health
• Intervention / Treatment: Behavioral: Midwife-led childbirth review (MLCR)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 1300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michal Zikan, MD, PhD; Phone Number: +420266083229; Email: michal.zikan@bulovka.cz

Study Locations

• Czechia
  • Brno, Czechia, 60200
    • University Hospital Brno
    • Contact: Andrea Mensikova, PhD, MHM; Phone Number: +420 532 236 853; Email: mensikova.andrea@fnbrno.cz
    • Contact: Miloslava Kamenikova, Dr; Phone Number: +420 532 238 443; Email: kamenikova.miloslava@fnbrno.cz
    • Principal Investigator: Andrea Mensikova, PhD, MHM
    • Sub-Investigator: Miloslava Kamenikova, Dr
  • Prague, Czechia, 18100
    • Bulovka University Hospital
    • Contact: Michal Zikan, MD, PhD; Phone Number: +420266083229; Email: michal.zikan@bulovka.cz
    • Contact: Vera Stepanova; Phone Number: +420266083201; Email: vera.stepanova@bulovka.cz
    • Principal Investigator: Michal Zikan, MD, PhD
    • Sub-Investigator: Milada Baresova

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group A; MLCR within the first postpartum week.	Behavioral: Midwife-led childbirth review (MLCR); 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.
Experimental: Experimental group B; MLCR at 6-8 weeks postpartum	Behavioral: Midwife-led childbirth review (MLCR); 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.
Experimental: Experimental group C; MLCR both within the first postpartum week and at 6-8 weeks postpartum	Behavioral: Midwife-led childbirth review (MLCR); 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depressive symptoms measured via the Edinburgh Postnatal Depression Scale (EPDS)	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.	Baseline (third trimester of pregnancy), 6-8 weeks postpartum, 6 months postpartum
Perinatal anxiety symptoms measured via the Perinatal Anxiety Screening Scale (PASS)	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.	Baseline (third trimester of pregnancy), 6-8 weeks postpartum, 6 months postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety symptoms measured via the State-Trait Anxiety Inventory - state - short 5-item version (STAIS-5)	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.	Baseline (third trimester of pregnancy), within the first postpartum week, 6-8 weeks postpartum, 6 months postpartum
Anxiety symptoms measured via the Generalized Anxiety Disorder Scale (GAD-7)	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.	Baseline (third trimester of pregnancy), 6-8 weeks postpartum, 6 months postpartum
Maternal parenting self-esteem measured via the Maternal Self-report Inventory (MSRI)	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.	Baseline (third trimester of pregnancy), 6-8 weeks postpartum, 6 months postpartum
Parenting self-esteem measured via the Parenting Sense of Competence Scale (PSOC)	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.	6 months postpartum
Maternal bonding to the infant measured via the Maternal Postnatal Attachment Scale (MPAS)	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.	6-8 weeks postpartum, 6 months postpartum
Paternal bonding to the infant measured via the Paternal Postnatal Attachment Scale (PPAS)	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.	6-8 weeks postpartum, 6 months postpartum
Sleep quality measured via the Pittsburgh Sleep Quality Index	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.	Baseline (third trimester of pregnancy), 6-8 weeks postpartum, 6 months postpartum
Relationship satisfaction measured via the Relationship Assessment Scale (RAS)	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.	Baseline (third trimester of pregnancy), 6-8 weeks postpartum, 6 months postpartum
Perceived stress measured via the Perceived Stress Scale (PSS)	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.	Baseline (third trimester of pregnancy), 6-8 weeks postpartum, 6 months postpartum
Birth experience measured via the Birth Experiences Questionnaire (BEQ)	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.	Within the first postpartum week, 6-8 weeks postpartum, 6 months postpartum
Childbirth-related post-traumatic stress symptoms measured via the City Birth Trauma Scale (CityBiTS)	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.	6-8 weeks postpartum, 6 months postpartum
Mother-infant interaction quality observed during a free play, assessed via coding scheme developed by Gartstein et al. (2008, 2018)	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.	6 months postpartum
Future reproductive choices assessed via the questionnaire items developed specifically for the purposes of this study.	Questions focusing on preferred mode of delivery in future childbirth, intention to have another child, and intention to postpone future pregnancy.	6 months postpartum

Collaborators and Investigators

• Sponsor: Charles University, Czech Republic
• Collaborators: Brno University Hospital; Masaryk University; Bulovka Hospital
• Investigators: Study Director: Lea Takacs, PhD, Masaryk University; Principal Investigator: Michal Zikan, MD, PhD, Bulovka University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): July 6, 2026
• Primary Completion (Estimated): March 15, 2028
• Study Completion (Estimated): July 15, 2028

Study Registration Dates

• First Submitted: June 25, 2026
• First Submitted That Met QC Criteria: June 25, 2026
• First Posted (Actual): July 1, 2026

Study Record Updates

• Last Update Posted (Actual): July 1, 2026
• Last Update Submitted That Met QC Criteria: June 25, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Parenting; Perinatal mental health; Postpartum debriefing; Midwife-led childbirth review; Postpartum adjustment
• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Mood Disorders; Puerperal Disorders; Depressive Disorder; Depression, Postpartum
• Other Study ID Numbers: AZV-NW25-09-00321; NW25-09-00321 (Other Grant/Funding Number: Czech Health Research Council)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: A deidentified data will be shared at the request of qualified investigators for the purpose of further research.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No