UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057240 |
|---|---|
| Receipt number | R000060579 |
| Scientific Title | Evaluation of a Program for Promoting Respectful Maternity Care in Rural Guatemala: A Quasi-Experimental Study |
| Date of disclosure of the study information | 2025/03/08 |
| Last modified on | 2025/12/20 10:17:57 |
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Basic information
Public title
Evaluation of a Program for Promoting Respectful Maternity Care in Rural Guatemala
Acronym
Evaluation of a Program on RMC
Scientific Title
Evaluation of a Program for Promoting Respectful Maternity Care in Rural Guatemala: A Quasi-Experimental Study
Scientific Title:Acronym
Evaluation of a Program on RMC
Region
| South America |
Condition
Condition
Pregnant women
Classification by specialty
| Obstetrics and Gynecology | Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the effectiveness of a program on respectful maternity care that was developed and will be implemented for nurses.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
women's experience of respectful maternity care during childbirth in the hospital
Key secondary outcomes
nurses' perception of respectful maternity care and women's experience of mistreatment during childbirth in the hospital
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
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
The educational program on respectful maternity care will be implemented for nurses involved in maternity care at the hospital. Nurses who have consented to participate in the study will be asked to attend two sessions of the program that last three hours.
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
Male and Female
Key inclusion criteria
all nurses involved in maternity care at the hospital
Key exclusion criteria
Nurses who have not given their consent
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Hina |
| Middle name | |
| Last name | Ikezoe |
Organization
Graduate School of St. Luke's International University
Division name
Graduate School of Nursing Science, Doctoral Program
Zip code
104-0044
Address
10-1, Akashi-cho, Chuo-ku, Tokyo
TEL
03-3543-6391
22dn002@slcn.ac.jp
Public contact
Name of contact person
| 1st name | Hina |
| Middle name | |
| Last name | Ikezoe |
Organization
St. Luke's International University
Division name
Graduate School of Nursing Science, Doctoral Program
Zip code
104-0044
Address
10-1, Akashi-cho, Chuo-ku, Tokyo
TEL
03-3543-6391
Homepage URL
22dn002@slcn.ac.jp
Sponsor or person
Institute
St. Luke's International University
Institute
Department
Personal name
Funding Source
Organization
YAMAJI FUMIKO NURSING RESEARCH FUND
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
Tel
03-5550-2423
kenkyukikaku@luke.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
| 2025 | Year | 03 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
50
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
| 2024 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 15 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 03 | Month | 08 | Day |
Last modified on
| 2025 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060579
