UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057241 |
|---|---|
| Receipt number | R000065412 |
| Scientific Title | Effectiveness of a group antenatal birth preparedness and complication readiness program among primigravida low-risk pregnant women in Mandalay, Myanmar |
| Date of disclosure of the study information | 2025/03/08 |
| Last modified on | 2025/11/17 14:01:04 |
* 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
Effectiveness of a group antenatal birth preparedness and complication readiness program among primigravida low-risk pregnant women in Mandalay, Myanmar: A quasi-experimental study
Acronym
Effectiveness of a group antenatal birth preparedness and complication readiness program among primigravida low-risk pregnant women in Mandalay, Myanmar
Scientific Title
Effectiveness of a group antenatal birth preparedness and complication readiness program among primigravida low-risk pregnant women in Mandalay, Myanmar
Scientific Title:Acronym
Effectiveness of a group antenatal birth preparedness and complication readiness program among primigravida low-risk pregnant women in Mandalay, Myanmar
Region
| Japan |
Condition
Condition
Pregnant women
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the effectiveness of birth preparedness intervention among pregnant women in Mandalay, Myanmar
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Knowledge of danger signs during pregnancy, knowledge of birth preparedness, knowledge of breastfeeding, and knowledge of newborn care at pre-test and post-test after intervention
Key secondary outcomes
complication readiness, and pregnancy-related empowerment scale at pre-test and post-test after intervention
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
| Behavior,custom |
Interventions/Control_1
80-minute health education session through lecture, video and discussion and answering of question on the day of the enrollment
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
English Primigravida
Age over 18 years
Low-risk pregnancy
At least 20 weeks into the pregnancy
Those who have given written consent to participate in this research
Key exclusion criteria
Healthcare professionals
Pregnancy with complications or underlying health problems
Pregnant women who cannot speak the Myanmar language
Target sample size
94
Research contact person
Name of lead principal investigator
| 1st name | Phyu |
| Middle name | Phyu |
| Last name | Tun |
Organization
English St. Luke's International University
Division name
Graduate School of Nursing
Zip code
135-0064
Address
2-2B512, Aomi, Koto-ku, Tokyo
TEL
080-9450-8720
22dn901@slcn.ac.jp
Public contact
Name of contact person
| 1st name | Phyu |
| Middle name | Phyu |
| Last name | Tun |
Organization
St. Luke's International University
Division name
Graduate School of Nursing
Zip code
135-0064
Address
2-2-B512, Aomi, Koto-ku, Tokyo
TEL
080-9450-8720
Homepage URL
22dn901@slcn.ac.jp
Sponsor or person
Institute
English St. Luke's Internatioanl Univesity
Institute
Department
Personal name
Funding Source
Organization
English St. Luke's Health Science Research Fund Shintaro Akatsu Young Scientist Incentive Program
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 Akashicho Chuo-ku Tokyo 104-0044 Japan
Tel
03-5565-1626
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
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
94
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 | 07 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 26 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 25 | Day |
Date of closure to data entry
| 2025 | Year | 01 | Month | 15 | Day |
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 | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065412
