UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043150 |
|---|---|
| Receipt number | R000049155 |
| Scientific Title | Effectiveness of an Early Skin-to-Skin Contact Program for Pregnant Women with caesarean section: A Quasi-Experimental Trial |
| Date of disclosure of the study information | 2021/01/28 |
| Last modified on | 2023/02/03 14:56:26 |
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Basic information
Public title
Effectiveness of an Early Skin-to-Skin Contact Program for Pregnant Women with caesarean section: A Quasi-Experimental Trial
Acronym
Effectiveness of an Early Skin-to-Skin Contact Program for Pregnant Women with caesarean section: A Quasi-Experimental Trial
Scientific Title
Effectiveness of an Early Skin-to-Skin Contact Program for Pregnant Women with caesarean section: A Quasi-Experimental Trial
Scientific Title:Acronym
Effectiveness of an Early Skin-to-Skin Contact Program for Pregnant Women with caesarean section: A Quasi-Experimental Trial
Region
| Africa |
Condition
Condition
Caesarean section
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effectiveness of the program. The hypothesis are follows; (1) The rate of complete breastfeeding will be higher 4 months after birth, (2) The rate of complete breastfeeding will be higher at 1-3 days,1 and 2 months after birth, (3) More likely to have intention of the exclusive breastfeeding until 6 months at 1-3 days,1 and 2 months after delivery, (4) The knowledge test of breastfeeding and early SSC will be a high score at 1-3 days after delivery , (5) Lower the visual analog scale score for the perioperative pain at 1-3 days after delivery, (6) the mothers have more satisfied with delivery at 1-3 days after delivery, (7) Less number of visits and hospitalizations for diarrhea and infectious diseases in infants at 1-3 days after delivery and 1, 2 and 4 months after birth.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of exclusive breastfeeding at 4 months after delivery.
Key secondary outcomes
Duration time of exclusive breastfeeding.The mother's intention to breastfeeding until six months. The knowledge test of breastfeeding and early SSC. The score of perioperative pain visual analogue scale. The score of the birth satisfaction scale-revised indicator. The number of infants' hospitalization acceding to diarrhea and infectious diseases. Duration time to hospitalization or death of infants.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Skin-to-skin contact during caesarean section
Interventions/Control_2
Normal care
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
All types of caesarean section (both elective and emergency), 18 years or older, 34 weeks' gestation or later, and Swahili-speaker.
Key exclusion criteria
Those who have difficulty communicating due to severe mental illness, severe anemia, severe pre-eclampsia, severe hypertension due to pregnancy, general anesthesia.
Target sample size
172
Research contact person
Name of lead principal investigator
| 1st name | Yumiko |
| Middle name | |
| Last name | Igarashi |
Organization
St. Luke's International University
Division name
Doctoral course
Zip code
104-0044
Address
10-1 Akashi-cho Chuo-ku 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
Doctoral course
Zip code
104-0044
Address
10-1 Akashi-cho Chuo-ku Tokyo, Japan
TEL
0335436391
Homepage URL
19dn002@slcn.ac.jp
Sponsor or person
Institute
St. Luke's International University
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
10-1 Akashi-cho Chuo-ku Tokyo, Japan
Tel
0335436391
19dn002@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
Muhimbili National Hospital (Dar es Sallam, Tanzania)
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 01 | Month | 28 | 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
Completed
Date of protocol fixation
| 2021 | Year | 01 | Month | 20 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 01 | Month | 27 | Day |
Last modified on
| 2023 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049155
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