UMIN-CTR Clinical Trial

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
Email	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
Email	pendostellam@gmail.com

Sponsor
Institute	St. Luke's International University School of Nursing Midwifery department
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049189