UMIN-CTR Clinical Trial

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

pregnancy. delivery

Classification by specialty

Obstetrics and Gynecology

Nursing

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

The University of Shiga Prefecture

Institute

Department

Personal name

Organization

Japanese Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

JAPAN

Co-sponsor

Kobe University Graduate School of Health Sciences

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

済生会吹田病院（大阪府）

Date of disclosure of the study information

2011

Year

11

Month

01

Day

URL releasing protocol

Publication of results

Partially published

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

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 related information

prospective examination

Registered date

2011

Year

10

Month

24

Day

Last modified on

2013

Year

11

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007811