UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062471 |
|---|---|
| Receipt number | R000071471 |
| Scientific Title | Development and Feasibility of Midwife-led Birth Review Considering for Psychological Birth Trauma |
| Date of disclosure of the study information | 2026/11/10 |
| Last modified on | 2026/11/09 13:19:33 |
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Basic information
Public title
Development and Feasibility of Midwife-led Birth Review Considering for Psychological Birth Trauma
Acronym
A study of Birth Review Considering for Psychological Birth Trauma
Scientific Title
Development and Feasibility of Midwife-led Birth Review Considering for Psychological Birth Trauma
Scientific Title:Acronym
A study of Birth Review Considering for Psychological Birth Trauma
Region
| Japan |
Condition
Condition
Psychological Birth Trauma
Classification by specialty
| Obstetrics and Gynecology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to develop a midwife-led birth review intervention considering the psychological birth trauma, and to evaluate its feasibility (validity of the study methodology, acceptability of the intervention, efficacy and safety of the intervention, and implementability).
Basic objectives2
Others
Basic objectives -Others
Intervention receipt rate and post-intervention attrition rate
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Methodological validity: Evaluate the intervention receipt rate and the attrition rates post-intervention, and at 1 and 3 months postpartum.
Key secondary outcomes
-Methodological validity: Calculate Cronbach's alpha for each scale among participating postpartum women.
-Postpartum women's acceptability: Evaluate intervention satisfaction immediately post-intervention and at 3 months postpartum using the Japanese Client Satisfaction Questionnaire (CSQ-8). Assess optimal timing/frequency and emotional changes via a custom questionnaire.
-Intervention efficacy: Measure childbirth-related PTSD symptoms (Japanese PTSD Checklist for DSM-5), postpartum depression (Edinburgh Postnatal Depression Scale), self-esteem (Japanese Rosenberg Self-Esteem Scale), sense of mastery (Japanese Sense of Mastery Scale), and birth experience (Japanese Birth Satisfaction Scale-Revised [Japanese-BSS-R]) at baseline (pre-intervention) and post-intervention, and 1 and 3 months postpartum.
-Intervention safety: Assess childbirth-related PTSD symptoms using the Japanese PTSD Checklist for DSM-5 at baseline, post-intervention, and 1 and 3 months postpartum.
-Midwives' acceptability: Conduct midwife interviews to evaluate the birth review's utility, ease/clarity of use, burden, fit with clinical needs, and improvement suggestions.
-Implementability: Evaluate completion rates, time efficiency, and midwife interviews regarding protocol adherence challenges, orientation appropriateness, and implementation barriers.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Intervention Group: Birth Review Considering for Psychological Birth Trauma
Within 4 days postpartum, a face-to-face birth review, developed based on meaning-making theory (Park, 2010) and midwife-led counseling by Gamble et al. (2009) effective in reducing posttraumatic stress symptoms after childbirth, will be conducted.
Interventions/Control_2
Control Group: Standard face-to-face birth review as part of routine care
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
Participants who meet all of the following criteria will be included. Recruitment will take place during the late stages of pregnancy.
(1) Female, aged 18 to under 50 at the time of consent
(2) Japanese is the first language of the participant
(3) At least 34 weeks pregnant
(4) Expecting to give birth
(5) Provided free and voluntary consent to participate in the study
Key exclusion criteria
Participants who meet any of the following criteria will be excluded.
(1) Receiving professional treatment for any mental illness (e.g., pharmacotherapy, cognitive behavioral therapy)
(2) Having experienced a stillbirth, neonatal death, or a serious congenital disorder in the infant during this delivery
(3) Wishing no birth review after delivery
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Aya |
| Middle name | |
| Last name | Tezuka |
Organization
Institute of Science Tokyo
Division name
Graduate School of Health Sciences
Zip code
1138510
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
0358037225
tezuka.a.4644@m.isct.ac.jp
Public contact
Name of contact person
| 1st name | Aya |
| Middle name | |
| Last name | Tezuka |
Organization
Institute of Science Tokyo
Division name
Graduate School of Health Sciences
Zip code
1138510
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
0358037225
Homepage URL
tezuka.a.4644@m.isct.ac.jp
Sponsor or person
Institute
Institute of Science Tokyo
Institute
Department
Personal name
Funding Source
Organization
Japan Academy of Midwifery
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee for Medical Sciences, Institute of Science Tokyo
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
Tel
0358034547
rinri.adm@tmd.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東京科学大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 11 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 09 | Month | 15 | Day |
Date of IRB
| 2026 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2026 | Year | 11 | Month | 16 | Day |
Last follow-up date
| 2027 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 08 | Month | 04 | Day |
Last modified on
| 2026 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071471
