UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006602 |
|---|---|
| Receipt number | 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 | 2025/04/25 17:45:07 |
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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
| Obstetrics 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
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
watanabe.ka@nurse.usp.ac.jp
Sponsor or person
Institute
The University of Shiga Prefecture
Institute
Department
Personal name
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
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
https://mol.medicalonline.jp/library/journal/download?GoodsID=cu2mater/2013/005403/071&name=0191-019
Publication of results
Partially published
Result
URL related to results and publications
https://mol.medicalonline.jp/library/journal/download?GoodsID=cu2mater/2013/005403/071&name=0191-019
Number of participants that the trial has enrolled
23
Results
The changes from first, second, and third trimester were as follows triglycerides (109.1(58.6SD),244.7(106.1SD),266.3(220.1SD), total cholesterol (183.6(32.1SD,262.0(50.6SD),40.0(64.1SD), and free fatty acids (0.35(0.11SD),0.46(0.18SD),0.54(0.21SD) were significantly higher in the late stage than in the early stages. Neutral fat levels during first trimester were negatively correlated with average number of steps and moderate-intensity exercise
Results date posted
| 2025 | Year | 04 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Average age:30.5(4.4SD), Birth weight: 3034(320.7SD) g, vaginal delivery: 18, Caesarean section:5. weight gain:10.1(3.3SD) kg. Employed: 17, Unemployed: 6.
Participant flow
Consented participants 25. Person who retracts consent 2. In the end, 23 people were included in the study.
Adverse events
none
Outcome measures
Blood glucose levels, HbA1c, Total cholesterol,Triglyceride,HDL,LDL,Physical activity
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
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
| 2025 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007811
