UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063516 |
|---|---|
| Receipt number | R000072636 |
| Scientific Title | Effect of Outreach Support on Breastfeeding Continuation: A Quasi-Experimental Study at Maternity Facilities in Fukushima Prefecture |
| Date of disclosure of the study information | 2026/11/04 |
| Last modified on | 2026/11/04 20:13:30 |
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Basic information
Public title
Effect of Midwife-Led Postdischarge Breastfeeding Support on Breastfeeding Continuation at Two Months Postpartum
Acronym
Effect of Midwife-Led Postdischarge Breastfeeding Support on Breastfeeding Continuation at Two Months Postpartum
Scientific Title
Effect of Outreach Support on Breastfeeding Continuation: A Quasi-Experimental Study at Maternity Facilities in Fukushima Prefecture
Scientific Title:Acronym
Effect of Outreach Support on Breastfeeding Continuation: A Quasi-Experimental Study at Maternity Facilities in Fukushima Prefecture
Region
| Japan |
Condition
Condition
Postpartum breastfeeding and breastfeeding continuation
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the association of postdischarge midwife-led outreach breastfeeding support with breastfeeding continuation at two months postpartum and perceived breastfeeding support, compared with usual care, among mothers delivering at maternity facilities in Fukushima Prefecture.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Breastfeeding continuation rate at two months postpartum, defined as breast milk accounting for at least 80% of total feeding.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
After discharge, trained community midwives provide breastfeeding support through telephone consultations, home visits, and consultations at midwifery clinics according to maternal needs and preferences. Additional support is offered as requested.
Interventions/Control_2
Mothers who do not request outreach support receive usual care without additional study-provided outreach support.
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
| 49 | years-old | >= |
Gender
Female
Key inclusion criteria
Mothers residing in Fukushima Prefecture or temporarily staying there for delivery; able to return home after discharge; intending to breastfeed. The criterion concerning preference for outreach support requires clarification because the control group comprises mothers who do not request support.
Key exclusion criteria
Unable to communicate in Japanese; unable to breastfeed due to medical conditions; or infant has a severe illness.
Target sample size
214
Research contact person
Name of lead principal investigator
| 1st name | Izumi |
| Middle name | |
| Last name | Sato |
Organization
Fukushima Medical University
Division name
Department of Maternal Nursing & Midwifery,Graduate school of Nursing
Zip code
2590123
Address
1hikarigaoka,fukushima,Japan
TEL
09033360451
i-sato@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Izumi |
| Middle name | |
| Last name | SATO |
Organization
Fukushima medical University
Division name
Department of Maternal Nursing & Midwifery, Graduate school
Zip code
2590123
Address
1hikarigaoka,fukushima,Japan
TEL
09033360451
Homepage URL
i-sato@fmu.ac.jp
Sponsor or person
Institute
Fukushima medical University
Institute
Department
Personal name
Izumi SATO
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukushima Medical University
Address
1hikarigaoka,fukushima,Japan
Tel
0245471953
i-sato@fmu.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
| 2026 | Year | 11 | Month | 04 | 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 | 07 | Month | 17 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 17 | Day |
Anticipated trial start date
| 2026 | Year | 11 | Month | 05 | Day |
Last follow-up date
| 2027 | Year | 06 | 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
| 2026 | Year | 11 | Month | 04 | Day |
Last modified on
| 2026 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072636
