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UMIN-CTR Clinical Trial |
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Name | UMIN ID |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000048524 |
Receipt No. | R000055115 |
Scientific Title | The Early Partnership Project: evaluation of a new community service |
Date of disclosure of the study information | 2022/08/01 |
Last modified on | 2022/07/29 |
Basic information | ||
Public title | The Early Partnership Project: evaluation of a new community service | |
Acronym | Evaluation of the Early Partnership Project | |
Scientific Title | The Early Partnership Project: evaluation of a new community service | |
Scientific Title:Acronym | Evaluation of the Early Partnership Project | |
Region |
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Condition | ||
Condition | Pregnant Women | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | Verify the effectiveness of new services aimed at improving shortcomings of existing child care support services, based on survey data from a cohort of pregnant women. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Maternal perceived capacity in life |
Key secondary outcomes | Maternal Service Usage
Maternal Service Satisfaction Maternal Attachment Information recorded in the Maternal & Child Healthcare Handbook (Birth weight, Gestational age at birth, maternal difficulty in childcare, etc.) Social Support Maternal mental well-being (WHO5) Maternal depression (EPDS) Maternal self esteem (Rosenberg self esteem scale) Maternal auditory hallucination experiences Maternal attitudes toward childcare |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Historical |
Stratification | NO |
Dynamic allocation | NO |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Prevention | |
Type of intervention |
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Interventions/Control_1 | Eligible women receive regular support from a trained Family Support Workers in the community from the time of conception through the first year postpartum.
Family Support Workers will support eligible women from early gregnancy up to 1 year after childbirth. The FSWs will hold multidisciplinary discussion meetings to evaluate lifestyle and psychological state etc., identify unmet needs, and establish action plans for the participating women. |
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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 |
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Age-upper limit |
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Gender | Female | |||
Key inclusion criteria | Pregnant women who will submit their pregnancy notification during the 8-month period from August 2022 to March 2023 (with the possibility of extension), who are first-time pregnant women between the ages of 16 and 25 and who are able to answer the questionnaire in Japanese. | |||
Key exclusion criteria | If an eligible pregnant woman is identified, but already has plans to move out of the municipality permanently, she will not be recruited to the program.
However, if the move is temporary (for example, in the case of returning to her hometown to give birth), she will be recruited. |
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Target sample size | 200 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Tokyo Metropolitan Institute of Medical Science Research Center | ||||||
Division name | Research Center for Social Science & Medicine Unit for Mental Health Promotion | ||||||
Zip code | 1568506 | ||||||
Address | 2-1-6 Kamikitazawa, Setagayaku, Tokyo | ||||||
TEL | +81-3-6834-2293 | ||||||
baba-kr@igakuken.or.jp |
Public contact | |||||||
Name of contact person |
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Organization | Tokyo Metropolitan Institute of Medical Science | ||||||
Division name | Research Center for Social Science & Medicine Unit for Mental Health Promotion | ||||||
Zip code | 1568506 | ||||||
Address | 2-1-6 Kamikitazawa, Setagayaku, Tokyo | ||||||
TEL | +81-3-6834-2293 | ||||||
Homepage URL | |||||||
baba-kr@igakuken.or.jp |
Sponsor | |
Institute | Tokyo Metropolitan Institute of Medical Science Research Center |
Institute | |
Department |
Funding Source | |
Organization | Commissioned by Tokyo Metropolitan Government |
Organization | |
Division | |
Category of Funding Organization | Local Government |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | Center for Medical Research Cooperation, Tokyo Metropolitan Institute of Medical Science |
Address | 2-1-6 Kamikitazawa, Setagaya-ku, Tokyo |
Tel | +81-3-6834-2391 |
renkei@igakuken.or.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 |
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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 | Preinitiation | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055115 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |