Midwife-led Childbirth Review and Psychological Outcomes in New Parents (NCT07678801) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Midwife-led Childbirth Review and Psychological Outcomes in New Parents
Czechia1,300 participantsStarted 2026-07-06
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is listed as 'not yet recruiting' — do you know when it's expected to open, and would it make sense for me to wait for it or start another form of support for postpartum mental health right now?
2The study uses midwife-led childbirth reviews to address postpartum depression and perinatal anxiety — given my specific situation, do you think a midwife-led approach is appropriate for me, or would a different mental health pathway be a better first step?
3Since this trial measures outcomes using the Edinburgh Postnatal Depression Scale and the Perinatal Anxiety Screening Scale, could we use those same tools now to get a baseline sense of where I stand, regardless of whether I join the study?
4Because this trial has no listed phase, it may be exploring whether this type of review is feasible or acceptable rather than proving it works — does that change how you'd weigh it against standard postpartum mental health treatments that already have more evidence behind them?
5What would participating in a midwife-led childbirth review actually involve in terms of time and appointments, and is that realistic given everything else I'll be managing in the postpartum period?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Depressive symptoms measured via the Edinburgh Postnatal Depression Scale (EPDS)