UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057624 |
|---|---|
| Receipt number | R000065764 |
| Scientific Title | The safety and effects of bathing in the early postpartum period |
| Date of disclosure of the study information | 2025/04/16 |
| Last modified on | 2025/04/15 20:50:18 |
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Basic information
Public title
The safety and effects of bathing in the early postpartum period
Acronym
The safety and effects of bathing in the early postpartum period
Scientific Title
The safety and effects of bathing in the early postpartum period
Scientific Title:Acronym
The safety and effects of bathing in the early postpartum period
Region
| Japan |
Condition
Condition
postpartum
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to assess the safety and efficacy of taking a bath in a hot tub immediately following hospital discharge after a vaginal delivery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of perineal wound infections and endometritis in the early postpartum period
Key secondary outcomes
perineal wound pain level, pelvic pain level, postpartum depression scores, and maternal satisfaction regarding bathing
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Prohibition of bathing in the bathtub until the postpartum checkup
Interventions/Control_2
Permission of bathing in the bathtub starting immediately after hospital discharge
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
| 60 | years-old | >= |
Gender
Female
Key inclusion criteria
Patients who underwent vaginal delivery at the National Center for Child Health and Development or the National Center for Global Health and Medicine
Patients who attended a postpartum checkup at the National Center for Child Health and Development or the National Center for Global Health and Medicine
Patients who provided written informed consent to participate in the study
Key exclusion criteria
Cases diagnosed with perineal wound infection or endometritis before discharge following delivery
Cases of fourth-degree perineal laceration
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | RINKO |
| Middle name | |
| Last name | IBI |
Organization
National Center for Child Health and Development
Division name
Obstetrics
Zip code
157-8535
Address
2-10-1 Okura, Setagaya-ku, Tokyo, Japan
TEL
03-3416-0181
ibi-r@ncchd.go.jp
Public contact
Name of contact person
| 1st name | RINKO |
| Middle name | |
| Last name | IBI |
Organization
National Center for Child Health and Development
Division name
Obstetrics
Zip code
1570074
Address
2-10-1 Okura, Setagaya-ku, Tokyo, Japan
TEL
03-3416-0181
Homepage URL
ibi-r@ncchd.go.jp
Sponsor or person
Institute
National Center for Child Health and Development
Institute
Department
Personal name
Funding Source
Organization
Japan Health Research Promotion Bureau
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Child Health and Development
Address
2-10-1 Okura, Setagaya-ku, Tokyo, Japan
Tel
03-3416-0181
ibi-r@ncchd.go.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
| 2025 | Year | 04 | Month | 16 | 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
632
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 07 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 13 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 04 | Month | 15 | Day |
Last modified on
| 2025 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065764
