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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000006602
Receipt No. R000007811
Scientific Title Study on development of physical activity education program for comfortable pregnancy life and delivery
Date of disclosure of the study information 2011/11/01
Last modified on 2013/11/25

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Basic information
Public title Study on development of physical activity education program for comfortable pregnancy life and delivery
Acronym Study on development of physical activity education program for comfortable pregnancy life and delivery
Scientific Title Study on development of physical activity education program for comfortable pregnancy life and delivery
Scientific Title:Acronym Study on development of physical activity education program for comfortable pregnancy life and delivery
Region
Japan

Condition
Condition pregnancy. delivery
Classification by specialty
Obsterics and gynecology Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Comfortable pregnancy life indicator and the development of the physical activity education program for delivery.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes Changing of serum lipid, sugar, CRP, and cortisol by physical activity.estimate of delivery.
Key secondary outcomes pregnancy:serum lipid, sugar, cortisol, CRP,weight, presence or absence of abnormal, BP, fetal well-being
delivery:labor pain, bleeding, birthweight, mode of delivery,
presence or absence of abnormal

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
40 years-old >=
Gender Female
Key inclusion criteria It makes it to the pregnant woman who corresponds to the following that consult a physician the pregnant woman medical check up on 12 - 15 weeks of gestation.
Key exclusion criteria 1) Do possess the anomalous pregnancy passage such as complication, partus praematurus, and PIH.
2) Do possess the trouble etc. that influence other pregnancy passage.
3) Do a special physical activity like the maternity swimming etc.
4) Pregnant woman who do not agree to participant in this trial.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kaori Watanabe
Organization The University of Shiga Prefecture
Division name School of Human Nursing
Zip code
Address 2500 Hassaka-cho, Hikone, Shiga 522-8533 JAPAN
TEL 0749-28-8665
Email watanabe.ka@nurse.usp.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kaori Watanabe
Organization The University of Shiga Prefecture
Division name School of Human Nursing
Zip code
Address 2500 Hassaka-cho, Hikone, Shiga 522-8533 JAPAN
TEL 0749-28-8665
Homepage URL
Email watanabe.ka@nurse.usp.ac.jp

Sponsor
Institute The University of Shiga Prefecture
Institute
Department

Funding Source
Organization Japanese Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization JAPAN

Other related organizations
Co-sponsor Kobe University Graduate School of Health Sciences
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 済生会吹田病院(大阪府)

Other administrative information
Date of disclosure of the study information
2011 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Participants was 23 nulliparous with singleton pregnancy. Triglyceride, total cholesterol, free fatty acid was significantly increased at the third trimester than the first trimester Triglyceride of first trimester, second trimester, third trimester was 109.1(58.6SD), 244.7(106.1SD), 266.3(220.1SD) respectively. Total cholesterol of first trimester, second trimester, third trimester was 183.6(32.1SD), 262.0(50.6SD), 240.0(64.1SD) respectively. Fee fatty acid of first trimester, second trimester, third trimester was 0.35(0.11SD), 0.46(0.18SD), 0.54(0.21SD) respectively. There was no significant change in high-sensitivity CRP (0.13(0.11SD), 0.16(0.14SD), 0.15(0.13SD). There was no significant change glucose and LDL. Triglyceride in first trimester was a negative correlation between exercise intensity average number of steps, medium and high strength. There was a negative correlation to LDL and exercise intensity strong end of pregnancy.
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 Enrolling by invitation
Date of protocol fixation
2011 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 11 Month 01 Day
Last follow-up date
2013 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2013 Year 12 Month 01 Day

Other
Other related information prospective examination

Management information
Registered date
2011 Year 10 Month 24 Day
Last modified on
2013 Year 11 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007811

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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