UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of the appropriate amount of physical activity for the pregnant woman; using the wearable accelerometer
Title of the study (Brief title)	Evaluation of the appropriate amount of physical activity for the pregnant woman; using the wearable accelerometer
Region	Japan

Condition
Condition	Pregnant Women
Classification by specialty	Obsterics and gynecology Nursing
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate appropriate amount of physical activity for the pregnant woman
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence of threatened preterm labor
Key secondary outcomes	Incidence of Gestational diabetes, Pregnancy-induced hypertension, abnormality at delivery, weight increment during pregnancy

Base
Study type	Observational

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	singleton primipara after 24 gestation weeks, who agree to participate in this study, answer questionnaires, 17=<BMI<=25, do not have exercise habit, do not have any limitation to activity and exercise,
Key exclusion criteria	Women who do not agree to participate in this study. Women that a skin trouble is predicted by putting on accelerometer.
Target sample size	60

Research contact person
Name of lead principal investigator	Yasuka NAKAMURA
Organization	Tohoku University
Division name	Graduate school of Medicine Womens health nirsing
Address	2-1 Seiryo-machi, Aoba-ku, sendai, miyagi, JAPAN
TEL	022-717-7957
Email	ynaka@tohoku.ac.jp

Public contact
Name of contact person	Yasuka NAKAMURA
Organization	Tohoku University
Division name	Graduate school of Medicine Womens health nirsing
Address	2-1 Seiryo-machi, Aoba-ku, sendai, miyagi, JAPAN
TEL	022-717-79
Homepage URL
Email	ynaka@tohoku.ac.jp

Sponsor
Institute	Tohoku University
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

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	2016 Year 04 Month 29 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 12 Month 21 Day
Anticipated trial start date	2016 Year 03 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	a

Management information
Registered date	2016 Year 04 Month 28 Day
Last modified on	2018 Year 10 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022900