UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045482
Receipt number R000051188
Scientific Title Development of Preparation Program toward Childbirth and Childcare for Primiparas Over 35 Years Old
Date of disclosure of the study information 2021/09/14
Last modified on 2022/02/25 12:59:11

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Basic information

Public title

Development of Preparation Program toward Childbirth and Childcare for Primiparas Over 35 Years Old

Acronym

Development of Preparation Program toward Childbirth and Childcare for Primiparas Over 35 Years Old

Scientific Title

Development of Preparation Program toward Childbirth and Childcare for Primiparas Over 35 Years Old

Scientific Title:Acronym

Development of Preparation Program toward Childbirth and Childcare for Primiparas Over 35 Years Old

Region

Japan


Condition

Condition

Primiparas Over 35 Years Old

Classification by specialty

Nursing

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To develop a program to prepare the mind and body for childbirth and childcare as midwifery care for older primiparas.

Basic objectives2

Others

Basic objectives -Others

To conduct process evaluation of the program for refining the program.

Trial characteristics_1

Others

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

The primary outcome is the implementation outcome.
We will evaluate the program's (1) acceptability, (2) appropriateness, (3) feasibility, (4) fidelity, and (5) sustainability among the study participants. The evaluation will be conducted during the program participation and at two weeks after the end of the program.

Key secondary outcomes



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

The research participants will receive a total of three sessions to be conducted with the researcher. Each session will focus on one of the following three items: "move your body," "get good rest," and "keep your body warm." The effectiveness of each item will be demonstrated, and the research participants will be encouraged to make a plan to "practice" it at home and carry it out.

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

35 years-old <=

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

(1) age 35 years or older at the time of pregnancy, (2) pregnant with a singleton, (3) 24 to 28 weeks gestation at the time of the start of the program, (4) if there are accidental complications or pregnancy complications, the physician in charge of the medical checkup has determined that the patient can participate in the program, and (5) the pregnant woman wishes to participate in the program.

Key exclusion criteria

(1) pregnancy complication or accidental complication requiring hospitalization (hospitalization is considered), (2) cervical canal length less than 30 mm or after cervical suture, (3) estimated fetal weight less than -1.5 SD, (4) mental illness and under treatment, (5) unable to speak, read and write in Japanese

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Chihiro
Middle name
Last name Kato

Organization

Tokyo Women's Medical University Yachiyo Medical Center

Division name

the nursing department

Zip code

276-8524

Address

477-96, Owada Shinden, Yachiyo City, Chiba

TEL

047-450-6000

Email

kato.chihiro@twmu.ac.jp


Public contact

Name of contact person

1st name Chihiro
Middle name
Last name Kato

Organization

Tokyo Women's Medical University Yachiyo Medical Center

Division name

the nursing department

Zip code

276-8524

Address

477-96, Owada Shinden, Yachiyo City, Chiba

TEL

047-450-6000

Homepage URL


Email

kato.chihiro@twmu.ac.jp


Sponsor or person

Institute

St. Luke's International University, Graduate School of Nursing

Institute

Department

Personal name



Funding Source

Organization

private expense

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

Tokyo Women's Medical University, Research Promotion Center, Research Management Division, Office of the Ethics Review Committee

Address

8-1 Kawada-cho, Shinjuku-ku, Tokyo

Tel

03-3353-8112(38276)

Email

rinri.bm@twmu.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

東京女子医科大学八千代医療センター(千葉県)


Other administrative information

Date of disclosure of the study information

2021 Year 09 Month 14 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

10

Results

The programme was feasible for the study participants and was generally able to achieve the objectives of the programme.

Results date posted

2022 Year 02 Month 25 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

The mean age of the study participants was 40.6 years, and all 10 had undergone fertility treatment leading to their current pregnancy. 80% of them had comorbidities or pregnancy complications.

Participant flow

Of the 14 study participants who met the inclusion criteria, 10 agreed to participate in the study. Of the 10 who participated in the study, 9 completed the programme. All nine participants who completed the programme agreed to complete the questionnaire and interviews. The valid response rate was 100%.

Adverse events

No adverse events.

Outcome measures

(1) Acceptability, (2) Appropriateness, (3) Feasibility, (4) Fidelity, and (5) Sustainability among the study participants at two weeks after the end of the program.
Content on changes in attitudes and behaviour of research participants extracted from qualitative data.

Plan to share IPD

None

IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2021 Year 06 Month 23 Day

Date of IRB

2021 Year 08 Month 23 Day

Anticipated trial start date

2021 Year 09 Month 01 Day

Last follow-up date

2021 Year 12 Month 31 Day

Date of closure to data entry

2022 Year 03 Month 30 Day

Date trial data considered complete

2022 Year 03 Month 30 Day

Date analysis concluded

2022 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2021 Year 09 Month 14 Day

Last modified on

2022 Year 02 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051188


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name