UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028789 |
|---|---|
| Receipt number | R000032947 |
| Scientific Title | Effectiveness of a Breastfeeding Self-Efficacy Intervention in a Baby-Friendly Hospital in Lao, PDR |
| Date of disclosure of the study information | 2017/09/17 |
| Last modified on | 2019/05/06 13:22:06 |
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Basic information
Public title
Effectiveness of a Breastfeeding Self-Efficacy Intervention in a Baby-Friendly Hospital in Lao, PDR
Acronym
Effectiveness of a Breastfeeding Self-Efficacy Intervention in a Baby-Friendly Hospital in Lao, PDR
Scientific Title
Effectiveness of a Breastfeeding Self-Efficacy Intervention in a Baby-Friendly Hospital in Lao, PDR
Scientific Title:Acronym
Effectiveness of a Breastfeeding Self-Efficacy Intervention in a Baby-Friendly Hospital in Lao, PDR
Region
| Asia(except Japan) |
Condition
Condition
Healthy women
Classification by specialty
| Obstetrics and Gynecology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to assess the effectiveness of breastfeeding support by nurses and midwives who attended a capacity-building program on maternal breastfeeding self-efficacy and breastfeeding duration and exclusivity in a Baby-Friendly Hospital in Lao PDR.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Infant feeding status 6 weeks, 14 weeks, and 6 months postpartum
Key secondary outcomes
Breastfeeding self-efficacy 6 weeks and 14 weeks postpartum
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Women in the control group will receive conventional breastfeeding support in the hospital and in the community.
Interventions/Control_2
Women in the intervention group will also receive conventional breastfeeding support. Those in the intervention group will also receive individual breastfeeding counseling, based on their responses to the Breastfeeding Self-Efficacy Scale -Short From, which consists of 14 items relating to breastfeeding practices. Before discharge, they receive face-to-face individual breastfeeding counseling by a trained nurse or midwife for about 15-to-30 minutes. After discharge, women will receive a phone call 1 week, 3 weeks, and 9 weeks after birth by a trained nurse or midwife to talk about any breastfeeding difficulties. Each session of telephone counseling will take about 5-to-15 minutes.
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
Eligibility criteria include the ability to participate in Laotian, and having had a singleton birth.
Key exclusion criteria
If either the women or her infant has a medical condition that can interfere with breastfeeding, she will be excluded from the study.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Keiko |
| Middle name | |
| Last name | Nanishi |
Organization
The University of Tokyo
Division name
Graduate School of Medicine
Zip code
113-0033
Address
Office of International Academic Affairs, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-5841-3689
keiko50@m.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Nanishi |
Organization
The University of Tokyo
Division name
Graduate School of Medicine
Zip code
113-0033
Address
Office of International Academic Affairs, Graduate School of Medicine, The University of Tokyo, 7-3-
TEL
03-5841-3689
Homepage URL
keiko50@m.u-tokyo.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Lao Tropical and Public Health Institute, Ministry of Health, Lao People's Domestic Republic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, The University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel
03-5841-0818
ethics@m.u-tokyo.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
Mother and Child Hospital in Vientiane
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 09 | Month | 17 | 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
392
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
| 2017 | Year | 05 | Month | 12 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 17 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 18 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 23 | Day |
Last modified on
| 2019 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032947
