UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053129 |
|---|---|
| Receipt number | R000060629 |
| Scientific Title | Post-Cesarean Intervention and Their Effectivness of Breastfeeding Support in Full-Term Infant: A Mapping Review |
| Date of disclosure of the study information | 2024/01/22 |
| Last modified on | 2023/12/16 13:10:18 |
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Basic information
Public title
Post-Cesarean Intervention and Their Effectivness of Breastfeeding Support in Full-Term Infant: A Mapping Review
Acronym
Post-Cesarean Intervention and Their Effectivness of Breastfeeding Support in Full-Term Infant: A Mapping Review
Scientific Title
Post-Cesarean Intervention and Their Effectivness of Breastfeeding Support in Full-Term Infant: A Mapping Review
Scientific Title:Acronym
Post-Cesarean Intervention and Their Effectivness of Breastfeeding Support in Full-Term Infant: A Mapping Review
Region
| Japan |
Condition
Condition
Breastfeeding of Post-Cesarean
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to conduct a mapping review of the existing literature to identify available interventions and assess their effectiveness in providing breastfeeding support after cesarean section.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Duration of Breastfeeding
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 43 | years-old | >= |
Gender
Female
Key inclusion criteria
a) Population: Include women who underwent cesarean section
b) Concept: Includes various early post-cesarean interventions and their effects on breastfeeding in maternity facilities
c) Context: Any developed or developing country with a facility that provides maternity care including but not limited to caesarean sections (e.g. hospitals and clinics)
d) Study design: Include randomized controlled trials (including cluster RCTs),
Key exclusion criteria
Reports in the literature on preterm infants, low-birth-weight infants, very low-birth-weight infants, and infants admitted to the NICU will be excluded. Report in the literature on women with serious physical or mental complications will be excluded.
Reports in the literature involving observational studies without interventions (e.g., impact of breastfeeding after cesarean section) and those not involving cesarean section will also be excluded.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | AI |
| Middle name | |
| Last name | MIYAUCHI |
Organization
St. Luke's International University Graduate School
Division name
Ph.D. Program
Zip code
104-0045
Address
3-8-5 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan Building 2, St. Luke's International University
TEL
03-3543-6391
23dn014@slcn.ac.jp
Public contact
Name of contact person
| 1st name | AI |
| Middle name | |
| Last name | MIYAUCHI |
Organization
St. Luke's International University Graduate School
Division name
Ph.D. Program
Zip code
104-0045
Address
3-8-5 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan Building 2, St. Luke's International University
TEL
03-3543-6391
Homepage URL
23dn014@slcn.ac.jp
Sponsor or person
Institute
St.Luke's International University Graduate School
Institute
Department
Personal name
Funding Source
Organization
Self-funding
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
St.Luke's International University
Address
3-8-5 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan Building 2, St. Luke's International University
Tel
03-3543-6391
23dn014@slcn.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
| 2024 | Year | 01 | Month | 22 | 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
| 2023 | Year | 12 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 12 | Month | 16 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Conducted a systematic keyword search in medical literature databases to explore breastfeeding support interventions post-Cesarean section. Developed a PRISMA Flow Chart to visualize the screening and selection process. Summarized key literature characteristics and presented outcomes of interventions and their effects through tables and figures.
Management information
Registered date
| 2023 | Year | 12 | Month | 16 | Day |
Last modified on
| 2023 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060629
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
