UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000053678
Receipt number R000061255
Scientific Title Nursing/midwifery care and the effectiveness of care for mothers and babies during the COVID-19 pandemic: a scoping review
Date of disclosure of the study information 2024/02/21
Last modified on 2025/02/21 11:20:56

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Basic information

Public title

Nursing/midwifery care and the effectiveness of care for mothers and babies during the COVID-19 pandemic: a scoping review

Acronym

Nursing/midwifery care and the effectiveness of care for mothers and babies during the COVID-19 pandemic: a scoping review

Scientific Title

Nursing/midwifery care and the effectiveness of care for mothers and babies during the COVID-19 pandemic: a scoping review

Scientific Title:Acronym

Nursing/midwifery care and the effectiveness of care for mothers and babies during the COVID-19 pandemic: a scoping review

Region

Japan


Condition

Condition

pregnancy and delivery

Classification by specialty

Nursing

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To identify perinatal nursing/midwifery care practiced under COVID-19 infection spread and its effectiveness from previous studies.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Care received from pregnancy to less than one year postpartum and its effects.

Key secondary outcomes



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

15 years-old <=

Age-upper limit

60 years-old >=

Gender

Female

Key inclusion criteria

Original papers published in Japanese and English describing the intervention and its effects

Key exclusion criteria

Secondary literature, guidelines, case studies, qualitative studies.

Target sample size



Research contact person

Name of lead principal investigator

1st name Toshiko
Middle name
Last name Igarashi

Organization

Nara Medical University

Division name

Department of Maternal Nursing

Zip code

6348521

Address

840 Shijo-Cho, Kashihara, Nara, Japan

TEL

0744-29-8941

Email

igarashi@naramed-u.ac.jp


Public contact

Name of contact person

1st name Toshiko
Middle name
Last name Igarashi

Organization

Nara Medical University

Division name

Department of Maternal Nursing

Zip code

6348521

Address

840 Shijo-Cho, Kashihara, Nara, Japan

TEL

0744-29-8941

Homepage URL


Email

igarashi@naramed-u.ac.jp


Sponsor or person

Institute

Nara Medical University

Institute

Department

Personal name



Funding Source

Organization

nothing

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

Nara Medical University

Address

840 Shijo-Cho, Kashihara, Nara, Japan

Tel

0744298941

Email

igarashi@naramed-u.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



Other administrative information

Date of disclosure of the study information

2024 Year 02 Month 21 Day


Related information

URL releasing protocol

N/A

Publication of results

Unpublished


Result

URL related to results and publications

N/A

Number of participants that the trial has enrolled

9

Results

Four studies from Japan were cross-sectional studies, examining the effectiveness of online maternity classes and the effectiveness of care for mother-infant separation in NICUs and other facilities.Five from overseas included studies on the effectiveness of an app-based telenursing service, the effectiveness of mobile clinics for postpartum mothers and children, and the effectiveness of education on Covid-19 fears related to breastfeeding.

Results date posted

2025 Year 02 Month 21 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Nine papers were accepted. The reporting countries were Japan, 4; Hong Kong, 1; Iran, 1; Turkey, 1; United States, 1; and Brazil, 1. The study designs were four cross-sectional studies, two practice reports, two cohort studies, one non-randomized controlled trial, and one randomized controlled trial.

Participant flow

One hundred eighty-five articles were extracted from the database. One hundred thirty-five duplicate references were excluded, and 1946 titles and abstracts were excluded from 1670 titles and abstracts. The full text of the papers was then read, and 12 were excluded.
Nine papers were accepted

Adverse events

None

Outcome measures

Satisfaction
Fear

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2023 Year 10 Month 01 Day

Date of IRB

2023 Year 10 Month 01 Day

Anticipated trial start date

2023 Year 10 Month 15 Day

Last follow-up date

2024 Year 02 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Nothing


Management information

Registered date

2024 Year 02 Month 21 Day

Last modified on

2025 Year 02 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061255