UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019605 |
|---|---|
| Receipt number | R000022581 |
| Scientific Title | the study of effect of domperidone as a galactagogue in mothers with insufficient milk supply |
| Date of disclosure of the study information | 2015/11/07 |
| Last modified on | 2015/11/24 19:58:25 |
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Basic information
Public title
the study of effect of domperidone as a galactagogue in mothers with insufficient milk supply
Acronym
the study of effect of domperidone
Scientific Title
the study of effect of domperidone as a galactagogue in mothers with insufficient milk supply
Scientific Title:Acronym
the study of effect of domperidone
Region
| Japan |
Condition
Condition
insufficient of milk supply
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
the effect and safety of domperidone for mothers with insufficient milk supply and for their babies
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
total milk volume on day7 and 14
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
domperidone 30mg/day for 14 days
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
| 15 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Female
Key inclusion criteria
mothers who experienced lactation failure at 2weeks after delivery
milk supply is under 300ml or inability to provide adequate breast milk to meet the daily nutritional intake of their infants
their infants are in NICU
Key exclusion criteria
mothers
1 who were already taking domperidone
2 who had previous bilateral breast surgery
3 who have allergies of domperidone
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fumio Suyama |
Organization
National Center for Child Health and Development
Division name
Maternal-Fetal and Neonatal Medicine
Zip code
Address
2-10-1 Okura Setagaya-Ku Tokyo-City
TEL
+81-3-3416-0181
suyama-f@ncchd.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fumio Suyama |
Organization
National Center for Child Health and Development
Division name
Maternal-Fetal and Neonatal Medicine
Zip code
Address
2-10-1 Okura Setagaya-Ku Tokyo-City
TEL
+81-3-3416-0181
Homepage URL
suyama-f@ncchd.go.jp
Sponsor or person
Institute
National Center for Child Health and Development
Institute
Department
Personal name
Funding Source
Organization
National Center for Child Health and Development
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
Address
Tel
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
| 2015 | Year | 11 | Month | 07 | 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
| 2015 | Year | 08 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 02 | Day |
Last modified on
| 2015 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022581
