UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033136 |
|---|---|
| Receipt number | R000037740 |
| Scientific Title | Perception of mothers who received early skin to skin contact after repeat caesarean section at Muhimbili National Hospital |
| Date of disclosure of the study information | 2018/07/01 |
| Last modified on | 2019/11/01 16:02:04 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Perception of mothers who received early skin to skin contact after repeat caesarean section at Muhimbili National Hospital
Acronym
Perception of mothers who received early skin to skin contact after repeat caesarean section at Muhimbili National Hospital
Scientific Title
Perception of mothers who received early skin to skin contact after repeat caesarean section at Muhimbili National Hospital
Scientific Title:Acronym
Perception of mothers who received early skin to skin contact after repeat caesarean section at Muhimbili National Hospital
Region
| Africa |
Condition
Condition
Elective repeat caesarean section
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore perception of mothers who received early skin to skin contact after elective repeat CS.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Satisfaction of delivery
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
| Maneuver |
Interventions/Control_1
Implementation of early skin to skin contact after elective repeat caesarean section
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Inclusion criteria are 1) women who are aged over 18 years, 2) gestation age is over 32 weeks, 3) native speaker of Swahili and 4) had one or more previous CS.
Key exclusion criteria
Exclusion criteria are high risk pregnancy with conditions such as psychiatry disease, severe anemia, severe pregnancy induced hypertension, and severe pre-eclampsia.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Yumiko |
| Middle name | |
| Last name | Igarashi |
Organization
St. Luke's International University
Division name
Master of nursing science
Zip code
104-0044
Address
10-1 Akashi-cho,chuoku, Tokyo, Japan
TEL
0335436391
19dn002@slcn.ac.jp
Public contact
Name of contact person
| 1st name | Yumiko |
| Middle name | |
| Last name | Igarashi |
Organization
St. Luke's International University
Division name
Master of nursing science
Zip code
104-0044
Address
10-1 Akashi-cho,chuoku, Tokyo, Japan
TEL
0335436391
Homepage URL
16mw301@slcn.ac.jp
Sponsor or person
Institute
St. Luke's International University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
St.Luke's International University
Address
10-1 Akashi-cho,chuoku, Tokyo, Japan
Tel
0335436391
16mw301@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
| 2018 | Year | 07 | Month | 01 | 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
17
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
Completed
Date of protocol fixation
| 2018 | Year | 06 | Month | 14 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 06 | Month | 25 | Day |
Last modified on
| 2019 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037740
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
