UMIN-CTR Clinical Trial

Basic information
Public title	Impact of physical activity on perinatal complications
Acronym	Impact of physical activity on perinatal complications
Scientific Title	Impact of physical activity on perinatal complications
Scientific Title:Acronym	Impact of physical activity on perinatal complications
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the impact of physical activity on prevention of prenatal complications such as gestational diabetes mellitus.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence of gestational diabetes mellitus
Key secondary outcomes	Incidence of difficult parturition

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	Adult pregnant women who agree to participate in the study and answer a questionnaire.
Key exclusion criteria	Subjects who do not agree to participate in the study answer a questionnaire.
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hideo Matsumoto
Organization	Keio University
Division name	Institute for Integrated Sports Medicine, School of Medicine
Zip code
Address	Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-3353-1211
Email	m-hideo@keio.jp

Public contact
Name of contact person	1st name Middle name Last name Shogo Tabata
Organization	Keio University
Division name	Institute for Integrated Sports Medicine, School of Medicine
Zip code
Address	Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-3353-1211
Homepage URL
Email	sky_walker_590718@yahoo.co.jp

Sponsor
Institute	Shogo Tabata
Institute
Department

Funding Source
Organization	Institute for Integrated Sports Medicine, School of Medicine, Keio University
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
Address
Tel
Email

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	2015 Year 05 Month 30 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	2015 Year 05 Month 11 Day
Date of IRB	2015 Year 04 Month 27 Day
Anticipated trial start date	2015 Year 06 Month 01 Day
Last follow-up date	2019 Year 04 Month 02 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	we will carry out a questionnaire about physical activity 3 times in first and third trimester and puerperal period.

Management information
Registered date	2015 Year 05 Month 26 Day
Last modified on	2019 Year 09 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020403