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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049189


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name