UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039415
Receipt number R000044936
Scientific Title Verification of the effects of comprehensive maternal and child care at the perinatal maternal and child medical center at Nakashibetsu Hospital
Date of disclosure of the study information 2020/02/06
Last modified on 2022/02/09 18:07:28

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Verification of the effects of comprehensive maternal and child care at the perinatal maternal and child medical center at Nakashibetsu Hospital

Acronym

Verification of the effects of comprehensive maternal and child care at the perinatal maternal and child medical center at Nakashibetsu Hospital

Scientific Title

Verification of the effects of comprehensive maternal and child care at the perinatal maternal and child medical center at Nakashibetsu Hospital

Scientific Title:Acronym

Verification of the effects of comprehensive maternal and child care at the perinatal maternal and child medical center at Nakashibetsu Hospital

Region

Japan


Condition

Condition

Maternal and child comprehensive care

Classification by specialty

Nursing

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Nine new items for maternal and child comprehensive care will be implemented at this facility from 2017.Comparisons will be made between 2011 and 2012 before maternal and child comprehensive care and after 2017 after the use of the Edinburgh Postnatal Depression Scale.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

Edinburgh Postnatal Depression Scale score

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Make room for mother and baby, breastfeeding frequently, make early mother-to-child contact, do not supplement unnecessary milk, avoid artificial nipples as much as possible, Care based on the Breast-feeding Infants'Suckling Mechanisms, prenatal guidance and nipple check Give birth, provide childcare guidance, and give a husband a childcare experience after childbirth

Interventions/Control_2

Do not perform intervention 1

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

16 years-old <=

Age-upper limit

44 years-old >=

Gender

Female

Key inclusion criteria

Obstetric women who delivered at our hospital

Key exclusion criteria

Targets corresponding to outliers

Target sample size

689


Research contact person

Name of lead principal investigator

1st name Taeko
Middle name
Last name Hosoya

Organization

Municipal Nakashibetsu Hospital

Division name

Nursing department

Zip code

086-1110

Address

9-1-1, Nishi 10-Jun Minami, Nishi 10-Ju, Nakashibetsu-cho, Shibetsu-gun, Hokkaido

TEL

0153728200

Email

tihaya@jru.ne.jp


Public contact

Name of contact person

1st name Taeko
Middle name
Last name Hosoya

Organization

Municipal Nakashibetsu Hospital

Division name

Nursing department

Zip code

086-1110

Address

9-1-1, Nishi 10-Jun Minami, Nishi 10-Ju, Nakashibetsu-cho, Shibetsu-gun, Hokkaido

TEL

0153728200

Homepage URL


Email

tihaya@jru.ne.jp


Sponsor or person

Institute

Municipal Nakashibetsu Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Municipal Nakashibetsu Hospital

Address

9-1-1, Nishi 10-Jun Minami, Nishi 10-Ju, Nakashibetsu-cho, Shibetsu-gun, Hokkaido

Tel

0153728200

Email

shima722@beach.ocn.ne.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

2020 Year 02 Month 06 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled

689

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

Main results already published

Date of protocol fixation

2019 Year 04 Month 03 Day

Date of IRB

2020 Year 01 Month 22 Day

Anticipated trial start date

2020 Year 01 Month 22 Day

Last follow-up date

2021 Year 11 Month 05 Day

Date of closure to data entry

2021 Year 11 Month 05 Day

Date trial data considered complete

2021 Year 11 Month 05 Day

Date analysis concluded

2021 Year 11 Month 05 Day


Other

Other related information



Management information

Registered date

2020 Year 02 Month 06 Day

Last modified on

2022 Year 02 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044936


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name