Midwife-led Childbirth Review and Psychological Outcomes in New Parents

NCT07678801 | Not Yet Recruiting

• 2 other identifiers: AZV-NW25-09-00321NW25-09-00321
• Study Type: interventional
• Target: 1,300
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Postpartum Depression (PPD); Perinatal Anxiety; Postpartum Mental Health

Keywords

Postpartum debriefing; Perinatal mental health; Midwife-led childbirth review; Parenting; Postpartum adjustment

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (13)

• Anxiety symptoms measured via the State-Trait Anxiety Inventory - state - short 5-item version (STAIS-5)

  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)

  Baseline (third trimester of pregnancy), 6-8 weeks postpartum, 6 months postpartum

• Maternal parenting self-esteem measured via the Maternal Self-report Inventory (MSRI)

  Baseline (third trimester of pregnancy), 6-8 weeks postpartum, 6 months postpartum

• Parenting self-esteem measured via the Parenting Sense of Competence Scale (PSOC)

  6 months postpartum

• Maternal bonding to the infant measured via the Maternal Postnatal Attachment Scale (MPAS)

  6-8 weeks postpartum, 6 months postpartum

Study Arms (4)

Experimental group A

EXPERIMENTAL

MLCR within the first postpartum week.

Behavioral: Midwife-led childbirth review (MLCR)

Experimental group B

EXPERIMENTAL

MLCR at 6-8 weeks postpartum

Behavioral: Midwife-led childbirth review (MLCR)

Experimental group C

EXPERIMENTAL

MLCR both within the first postpartum week and at 6-8 weeks postpartum

Behavioral: Midwife-led childbirth review (MLCR)

Control group (group D)

NO INTERVENTION

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.

Interventions

Midwife-led childbirth review (MLCR) BEHAVIORAL

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 group A; Experimental group B; Experimental group C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Charles University, Czech Republic: lead
• Brno University Hospital: collaborator
• Masaryk University: collaborator
• Bulovka Hospital: collaborator

Study Sites (2)

University Hospital Brno

Brno, 60200, Czechia

Location

Bulovka University Hospital

Prague, 18100, Czechia

Location

Related Publications (2)

• 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.

  BACKGROUND

• 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.

  PMID: 17673341 BACKGROUND

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Lea Takacs, PhD

  Masaryk University

  STUDY DIRECTOR

• Michal Zikan, MD, PhD

  Bulovka University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michal Zikan, MD, PhD

CONTACT

+420266083229; michal.zikan@bulovka.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Outcome assessors for observational coding will be blinded to group allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Four-arm parallel assignment. Group A will receive the intervention within the first postpartum week, group B will receive the intervention at 6-8 weeks postpartum, group C will receive the intervention at both time points, and group D will receive standard postpartum care.

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 1, 2026
• Study Start: July 6, 2026
• Primary Completion (Estimated): March 15, 2028
• Study Completion (Estimated): July 15, 2028
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

CZ (2)