UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000054204
Receipt number R000061890
Scientific Title Implementation Study for a Hospital-based Approach to Advanced Midwifery Continuity of Care for Women with Hyperglycemia
Date of disclosure of the study information 2024/04/20
Last modified on 2024/04/19 21:37:14

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Basic information

Public title

Implementation Study for Improving the Quality of Continuity of Care in Midwifery Practice

Acronym

Continuity of Care in Midwifery Practice

Scientific Title

Implementation Study for a Hospital-based Approach to Advanced Midwifery Continuity of Care for Women with Hyperglycemia

Scientific Title:Acronym

Hospital-based Midwifery Continuity Care for Hyperglycemia

Region

Japan


Condition

Condition

Gestational Diabetes Mellitus
Overt Diabetes in Pregnancy

Classification by specialty

Endocrinology and Metabolism Obstetrics and Gynecology Nursing
Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To implement and evaluate an evidence-based continuity of midwifery care program at the antenatal clinic of Hospital A, based on the continuity and coordination of care framework, for promoting continuous care and translating evidence into practice regarding gestational hyperglycemia.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1.Knowledge of midwives on care for gestational hyperglycemia, 2.Midwives' experience, confidence, and job satisfaction in caring for gestational hyperglycemia, 3.Breastfeeding rates at discharge and 1-month checkup, weight gain control, and large for gestational age (LGA) birth rate,4.Patient experience and satisfaction, 5.Physicians' clinical workload and healthcare costs, 6.fidelity, 7.feasibility, 8.appropriateness, 9.acceptability, 10.reach

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

NO

Dynamic allocation

NO

Institution consideration

Institution is considered as a block.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Behavior,custom Other

Interventions/Control_1

This project study is an implementation research aimed at improving the quality of continuous support for women with gestational hyperglycemia by implementing a continuity of midwifery care promotion program at the antenatal clinic of Hospital A, based on the World Health Organization's Continuity and Coordination of Care framework. In this project, a continuity of care program will be implemented for midwives assigned to the antenatal clinic, and they will provide antenatal care to women with gestational hyperglycemia following the care guidelines.

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

18 years-old <=

Age-upper limit

55 years-old >=

Gender

Female

Key inclusion criteria

women diagnosed with gestational hyperglycemia during pregnancy

Key exclusion criteria

pregestational diabetes mellitus

Target sample size

514


Research contact person

Name of lead principal investigator

1st name Mika
Middle name
Last name Kato

Organization

St. Luke's International University

Division name

Graduate School of Nursing

Zip code

104-0044

Address

10-1 Akashi-cho Chuo-ku Tokyo 1040044 JPN

TEL

03-3543-6391

Email

20dn102@slcn.ac.jp


Public contact

Name of contact person

1st name Mika
Middle name
Last name Kato

Organization

St. Luke's International University

Division name

Graduate School of Nursing

Zip code

104-0044

Address

10-1 Akashi-cho Chuo-ku Tokyo 1040044 JPN

TEL

03-3543-6391

Homepage URL


Email

20dn102@slcn.ac.jp


Sponsor or person

Institute

St. Luke's International University

Institute

Department

Personal name

Mika Kato


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

St. Luke's International University

Address

10-1 Akashi-cho Chuo-ku Tokyo 1040044 JPN

Tel

03-3543-6391

Email

20dn102@slcn.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 04 Month 20 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

Open public recruiting

Date of protocol fixation

2023 Year 09 Month 04 Day

Date of IRB

2023 Year 08 Month 03 Day

Anticipated trial start date

2024 Year 01 Month 05 Day

Last follow-up date

2024 Year 04 Month 30 Day

Date of closure to data entry

2024 Year 06 Month 30 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2024 Year 04 Month 19 Day

Last modified on

2024 Year 04 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061890


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name