UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057564 |
|---|---|
| Receipt number | R000065772 |
| Scientific Title | A Comparative Study of Hands-off and Hands-on Techniques in Midwife-Assisted Vaginal Delivery |
| Date of disclosure of the study information | 2025/04/09 |
| Last modified on | 2025/04/09 14:18:43 |
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Basic information
Public title
A Study on the Incidence of Perineal Lacerations Based on Different Delivery Assistance Techniques
Acronym
A Study on the Incidence of Perineal Lacerations Based on Different Delivery Assistance Techniques
Scientific Title
A Comparative Study of Hands-off and Hands-on Techniques in Midwife-Assisted Vaginal Delivery
Scientific Title:Acronym
A Comparative Study of Hands-off and Hands-on Techniques in Midwife-Assisted Vaginal Delivery
Region
| Japan |
Condition
Condition
parturient and neonate
Classification by specialty
| Obstetrics and Gynecology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to compare the incidence of perineal lacerations and neonatal outcomes between hands-off and hands-on techniques employed in obstetric facilities in Japan.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of Perineal Lacerations
Key secondary outcomes
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
| Maneuver |
Interventions/Control_1
hands-off
Interventions/Control_2
hands-on
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
| Not applicable |
Gender
Female
Key inclusion criteria
Prenatal check-ups after 30 weeks:
Multiparous women
Singleton pregnancy
Both the mother and fetus are progressing normally
Planned vaginal delivery
Written informed consent has been obtained
Key exclusion criteria
Exclusion criteria at thirty weeks of pregnancy:
Mothers infected with the following infectious diseases.
Abnormalities in the uterus, appendages, vagina, external genitalia, or pelvic region.
History of uterine surgery.
Presence of pregnancy-induced hypertension, glucose intolerance, heart disease, respiratory disease, kidney disease, thyroid disease, or mental illness.
Diagnosis of fetal congenital abnormalities.
Mothers whose estimated fetal weight deviates from the expected weight for gestational age.
Mothers who have received perineal warming or perineal massage for prevention of perineal lacerations after thirty weeks of pregnancy.
Individuals deemed unsuitable as research subjects based on the judgment of the researcher, midwife, or physician.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | yoshiko |
| Middle name | |
| Last name | maida |
Organization
National University Corporation, Kanazawa University
Division name
Department of Health Science, Graduate School of Medical Sciences
Zip code
920-0942
Address
5-11-80 Kodateno, Kanazawa City, Ishikawa Prefecture
TEL
076-265-2500
maida@staff.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | nozomi |
| Middle name | |
| Last name | uchie |
Organization
National University Corporation, Kanazawa University
Division name
Doctoral Program in Nursing Science, Department of Health Sciences
Zip code
920-0942
Address
5-11-80 Kodateno, Kanazawa City, Ishikawa Prefecture
TEL
090-2833-9421
Homepage URL
u2329022004@stu.kanazawa-u.ac.jp
Sponsor or person
Institute
National University Corporation, Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National University Corporation, Kanazawa University
Address
5-11-80 Kodateno, Kanazawa City, Ishikawa Prefecture
Tel
076-265-2090
irb@adm.kanazawa-u.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 09 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 18 | Day |
Last follow-up date
| 2030 | Year | 03 | 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
| 2025 | Year | 04 | Month | 09 | Day |
Last modified on
| 2025 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065772
