Midwife-led Childbirth Review and Psychological Outcomes in New Parents
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCharles University, Czech Republic
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Midwife-led childbirth review (MLCR)
BehavioralMLCR 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.
Treatment groups
1,300 Participants
are divided into 4 treatment groupsGroup A: Experimental group AExperimental treatment 1 intervention
Group B: Experimental group BExperimental treatment 1 intervention
Group C: Experimental group CExperimental treatment 1 intervention
Group D: Control group (group D)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (third trimester of pregnancy), 6-8 weeks postpartum, 6 months postpartum2
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.
Time frame
Baseline (third trimester of pregnancy), 6-8 weeks postpartum, 6 months postpartumSecondary outcomes
1
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.
Time frame
Baseline (third trimester of pregnancy), within the first postpartum week, 6-8 weeks postpartum, 6 months postpartum2
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.
Time frame
Baseline (third trimester of pregnancy), 6-8 weeks postpartum, 6 months postpartum3
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.
Time frame
Baseline (third trimester of pregnancy), 6-8 weeks postpartum, 6 months postpartum4
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.
Time frame
6 months postpartumSponsors and contacts
Click on the lead sponsor to view all of their trials.
Charles University, Czech Republic
Lead sponsor
Brno University Hospital
Collaborator
Masaryk University
Collaborator
Bulovka Hospital
Collaborator
Source ClinicalTrials.gov
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