UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000043085 |
|---|---|
| Receipt number | R000049189 |
| Scientific Title | Effect of the family planning Green Star decision aid in the choice for postpartum family planning among pregnant adolescents in Tanzania: facility-based quasi-experimental design |
| Date of disclosure of the study information | 2021/01/21 |
| Last modified on | 2021/01/21 21:56:11 |
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Basic information
Public title
Effect of the family planning Green Star decision aid in the choice for postpartum family planning among pregnant adolescents in Tanzania
Acronym
Effect of the FP Green Star DA in the choice for PPFP among PA, Tanzania
Scientific Title
Effect of the family planning Green Star decision aid in the choice for postpartum family planning among pregnant adolescents in Tanzania: facility-based quasi-experimental design
Scientific Title:Acronym
Effect of the FP Green Star DA in the choice for PPFP among PA, Tanzania
Region
| Africa |
Condition
Condition
Rapid repeat pregnancy in teenage
Classification by specialty
| Nephrology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect of the DA on decision conflict, knowledge, satisfaction, and utilization of postpartum family planning
Basic objectives2
Others
Basic objectives -Others
Effect of the Green Star decision aid in the choice for postpartum long-acting reversible family planning options among adolescent mothers in Mkuranga and Kisarawe district hospitals in the Pwani region, Tanzania
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Decisional conflict will be assessed at day one of recruitment (Time 1) and post-intervention (Time 4) after delivery on the discharge day.
Key secondary outcomes
Knowledge will be measured on day one of recruitment and day three.
Satisfaction with decision-making will be measured on day 4 after delivery on the discharge day. The subscale consists of four items on satisfaction with decision making. The higher the score the higher the person's satisfaction level and the lower the score the lower the person's satisfaction level.
Utilization. After the decision we shall monitor the type of method used by each participant from each arm after delivery, if it is IUCD, Implant, or none
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 10 | years-old | <= |
Age-upper limit
| 19 | years-old | >= |
Gender
Female
Key inclusion criteria
pregnant adolescents aged between 10-19, with 28-34 gestation weeks, consented to participate in a study, mentally and physically well, able to communicate in Kiswahili language
Key exclusion criteria
the pregnant adolescent who will report being receiving FP education/counseling from other programs/sources
Target sample size
66
Research contact person
Name of lead principal investigator
| 1st name | Stella |
| Middle name | Emmanuel |
| Last name | Mushy |
Organization
St. Luke's International University
Division name
School of Nursing
Zip code
1350064
Address
Odaiba, 2-2-B0422, Aomi, Koto-Ku, Tokyo
TEL
09065132225
pendostellam@gmail.com
Public contact
Name of contact person
| 1st name | Stella |
| Middle name | Emmanuel |
| Last name | Mushy |
Organization
St. Luke's International University
Division name
School of Nursing
Zip code
1350064
Address
Odaiba, 2-2-B0422, Aomi, Koto-Ku, Tokyo
TEL
09065132225
Homepage URL
pendostellam@gmail.com
Sponsor or person
Institute
St. Luke's International University
School of Nursing
Midwifery department
Institute
Department
Personal name
Funding Source
Organization
The Japan Society for the Promotion of Science (JSPS)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
JAPANESE
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 City, Tokyo 104-0044
Tel
4845266742
Jayne.Silva@sluhn.org
Secondary IDs
Secondary IDs
YES
Study ID_1
MUHAS-REC-1-2020-076
Org. issuing International ID_1
St. Luke's International University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
St. Luke's International University (Tokyo) 10-1 Akashicho, Chuo City,104-0044
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 01 | Month | 21 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 01 | Month | 29 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 12 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 12 | Month | 19 | Day |
Date trial data considered complete
| 2022 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 10 | Day |
Other
Other related information
The woman in the intervention group will receive a minimum of three visits at 28, 32, 36/38 weeks before she gives birth. We chose three visits because we believed that three education sessions will be sufficient enough for the participant to understand the methods and address all the barriers preventing her from using FP
Management information
Registered date
| 2021 | Year | 01 | Month | 21 | Day |
Last modified on
| 2021 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049189
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| Registered date | File name |
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