UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054787 |
|---|---|
| Receipt number | R000062609 |
| Scientific Title | Effects of a Birth Review Intervention on Postpartum Mental Status of Pregnant and Postpartum Women: Utilizing the EPDS, W-DEQ, and IES-R |
| Date of disclosure of the study information | 2024/06/26 |
| Last modified on | 2024/06/26 19:21:52 |
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Basic information
Public title
Research on Postpartum Depression and Birth Reviews
Acronym
Postpartum Depression and Birth Review Study
Scientific Title
Effects of a Birth Review Intervention on Postpartum Mental Status of Pregnant and Postpartum Women: Utilizing the EPDS, W-DEQ, and IES-R
Scientific Title:Acronym
Effects of a Birth Review Intervention on Postpartum Mental Status of Pregnant and Postpartum Women
Region
| Japan |
Condition
Condition
normal pregnant woman
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the study was to examine the impact of the birth review intervention on mental health conditions such as depression, fear of childbirth, and traumatic states from the last trimester of pregnancy to 3 months after delivery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Edinburgh Postpartum Depression Questionnaire (EPDS ), Fear of Parturition Scale (W-DEQ), Revised Event Impact Scale (IES-R)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
The midwives who assisted with the subject's delivery performed the birth review in a face-to-face setting within 48 hours, lasting 20 to 30 minutes. The midwives who conducted the birth review were those who had worked as midwives for at least five years and were working in the maternity ward of the hospital. The method and procedures for conducting the birth review were explained to the subject midwives at the beginning of the study to avoid any bias. The content of the birth review was a face-to-face interview in which the participants were asked what kind of birth they had this time, how they felt about it, whether there was anything that bothered them or left them feeling uneasy about the delivery, and how they felt after reflecting on the birth.
Interventions/Control_2
No birth review
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Adult women who attended the outpatient obstetrics department of a municipal general hospital in H prefecture and had a normal pregnancy.
Key exclusion criteria
Those under 20 years of age, those who cannot give consent, and those who have not had a normal pregnancy process.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Miho |
| Middle name | |
| Last name | Tatsuno |
Organization
Minamisoma City General Hospital
Division name
nursing department
Zip code
975-0033
Address
2-54-6 Takamicho, Haramachi-ku, Minamisoma-shi, Fukushima
TEL
080-5223-0074
once.in.a.lifetime.2424@ezweb.ne.jp
Public contact
Name of contact person
| 1st name | Miho |
| Middle name | |
| Last name | Tatsuno |
Organization
Minamisoma City General Hospital
Division name
Nursing department
Zip code
975-0033
Address
2-54-6 Takamicho, Haramachi-ku, Minamisoma-shi, Fukushima
TEL
080-5223-0074
Homepage URL
once.in.a.lifetime.2424@ezweb.ne.jp
Sponsor or person
Institute
Minamisoma City General Hospital
Institute
Department
Personal name
Funding Source
Organization
self-procurement
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Minamisoma City General Hospital Ethics Committee
Address
2-54-6 Takamicho, Haramachi-ku, Minamisoma-shi, Fukushima
Tel
0244-22-3181
sogo-hp-kangokenkyu@bz04.plala.or.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
60
Results
Comparing the EPDS, W-DEQ, and IES-R scores at birth and 1 month/3 months postpartum with and without intervention, only the IES-R showed a significant difference at 3 months postpartum (p<0.05). The change over time for each scale in each group was significantly different for the EPDS and IES-R (p<0.01). The change in each scale score at birth from baseline was significantly different between the EPDS and IES-R intervention groups (p<0.01).
Results date posted
| 2024 | Year | 06 | Month | 26 | Day |
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
Completed
Date of protocol fixation
| 2020 | Year | 02 | Month | 14 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 14 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 06 | Month | 26 | Day |
Last modified on
| 2024 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062609
