UMIN-CTR Clinical Trial

Basic information
Public title	Development of Remote Health Support for Nurses during Pregnancy and Childbirth
Acronym	Remote support for nurses during pregnancy/ childbirth
Scientific Title	Development of Remote Health Support for Nurses during Pregnancy and Childbirth
Scientific Title:Acronym	Remote support for nurses during pregnancy/ childbirth
Region	Japan

Condition
Condition	Pregnant nurses
Classification by specialty	Nursing Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study was to examine the effect of remote support for nursing professionals during pregnancy and childbirth.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Physical condition and mood during pregnancy and childbirth, Parenting Self-efficacy (Before intervention,20th,24th,28th,32th and 36th weeks of gestation, one month and two month after childbirth)
Key secondary outcomes	Self-care behavior intentions and the status of practical self-care behavior during pregnancy

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom Other
Interventions/Control_1	Once every four weeks, the intervention group will receive Evidence-Based information by internet service. Additionally, those in the intervention group can feel free to consult a midwife about distress or life during pregnancy.
Interventions/Control_2	The control group answers only questionnaire surveys.
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	20 years-old <
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	Healthy nurses who had normal pregnancies.
Key exclusion criteria	We exclusion criteria are nurses who had abnormal pregnancy and poor physical or mental condition.
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Yumiko Middle name Last name Otsuka-Sakuma
Organization	Setsunan University
Division name	Faculty of Nursing
Zip code	573-0101
Address	45-1 Nagaotoge-cho, Hirakata City, Osaka, 573-0101, Japan
TEL	+81(0)72-896-5870
Email	yumiko.sakuma@nrs.setsunan.ac.jp

Public contact
Name of contact person	1st name Yumiko Middle name Last name Otsuka-Sakuma
Organization	Setsunan University
Division name	Faculty of Nursing
Zip code	573-0101
Address	45-1 Nagaotoge-cho, Hirakata City, Osaka, 573-0101, Japan
TEL	+81(0)72-896-5870
Homepage URL
Email	yumiko.sakuma@nrs.setsunan.ac.jp

Sponsor
Institute	Faculty of Nursing, Setsunan University
Institute
Department

Funding Source
Organization	MEXT(Japan)
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	MEXT JSPS KAKENHI Grant

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Setsunan University
Address	45-1 Nagaotoge-cho, Hirakata City, Osaka, 573-0101, Japan
Tel	+81(0)72-896-5870
Email	yumiko.sakuma@nrs.setsunan.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	A病院(大阪府) 他

Other administrative information
Date of disclosure of the study information	2018 Year 12 Month 13 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	Completed
Date of protocol fixation	2018 Year 03 Month 30 Day
Date of IRB	2018 Year 03 Month 06 Day
Anticipated trial start date	2018 Year 12 Month 01 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry	2022 Year 03 Month 31 Day
Date trial data considered complete	2022 Year 03 Month 31 Day
Date analysis concluded	2022 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2018 Year 12 Month 13 Day
Last modified on	2021 Year 06 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040158