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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000016853
Receipt No. R000018211
Scientific Title Efficacy of health advice from healthcare professionals to pregnant women in order to prevent preterm birth and improve quality of life during pregnancy: a randomized controlled trial
Date of disclosure of the study information 2015/03/30
Last modified on 2019/04/09

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Basic information
Public title Efficacy of health advice from healthcare professionals to pregnant women in order to prevent preterm birth and improve quality of life during pregnancy: a randomized controlled trial
Acronym Study to evaluate the effectiveness of health advice to prevent preterm birth and improve quality of life
Scientific Title Efficacy of health advice from healthcare professionals to pregnant women in order to prevent preterm birth and improve quality of life during pregnancy: a randomized controlled trial
Scientific Title:Acronym Study to evaluate the effectiveness of health advice to prevent preterm birth and improve quality of life
Region
Japan

Condition
Condition Preterm birth
Classification by specialty
Obsterics and gynecology Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effectiveness of advice from healthcare professionals to pregnant women to avoid wearing trunk-constricting clothing in order to reduce the risk of premature birth and improve QOL during pregnancy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Premature birth
Key secondary outcomes 1. Tension and hardness of the abdominal wall
2. Temperature of the extremities and trunk region
3. Stress
4. Urinary incontinence
5. QOL
6. Location of fetal activity
7. Bowel evacuation problems
8. Gynecological complications
9. Perfusion volume of the umbilical artery
10.Birth weight
11. Cervical length
12. Admission to hospital for threatened premature delivery

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Leaflets on anemia prevention and skin care and advice from healthcare professionals to reduce the pressure of clothing in the trunk area at antenatal checkup
Interventions/Control_2 Leaflets on anemia prevention and skin care at antenatal checkup
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

Not applicable
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria All pregnant women scheduled to give birth at the facility where the study will be implemented
Key exclusion criteria (1) Pregnant women who undergo their first prenatal checkup after 20 weeks' gestation or later
(2) Pregnant women with psychiatric conditions
(3) Pregnant women with uterine deformity
(4) Pregnant women with previous uterine surgery
(5) Pregnant women who have undergone circumferential suture of the cervix
(6) Pregnant women with fetal diseases
(7) Pregnant women with suspected recurrent pregnancy loss
(8) Pregnant women whose cervical length is already less than 30 mm before the start of intervention
(9) Pregnant women who are already hospitalized
(10) Pregnant women whose participation has been judged by a doctor as undesirable
(11) Pregnant women who have difficulty to communicate in Japanese
Target sample size 616

Research contact person
Name of lead principal investigator
1st name Sachiko
Middle name
Last name Kato
Organization National Center for Child Health and Development
Division name Department of Nursing
Zip code 157-8535
Address 2-10-1, Okura, Setagaya-ku, Tokyo
TEL 03-3416-0181(4261)
Email kato-s@ncchd.go.jp

Public contact
Name of contact person
1st name Kenji
Middle name
Last name Takehara
Organization National Research Institute for Child Health and Development
Division name Department of Health Policy
Zip code 157-8535
Address 2-10-1, Okura, Setagaya-ku, Tokyo
TEL 03-3416-0181(4261)
Homepage URL
Email kato-s@ncchd.go.jp

Sponsor
Institute National Center for Child Health and Development
Institute
Department

Funding Source
Organization National Center for Child Health and Development
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 Ethics Committee National Center for Child Health & Development
Address 10-1, Okura 2chome, Setagaya, Tokyo, JAPAN
Tel 03-3416-0181 ex5927
Email rinri@ncchd.go.jp

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 国立成育医療研究センター(東京都)

Other administrative information
Date of disclosure of the study information
2015 Year 03 Month 30 Day

Related information
URL releasing protocol http://bmjopen.bmj.com/content/5/9/e008252
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 No longer recruiting
Date of protocol fixation
2015 Year 03 Month 06 Day
Date of IRB
Anticipated trial start date
2015 Year 03 Month 30 Day
Last follow-up date
2016 Year 08 Month 31 Day
Date of closure to data entry
2016 Year 11 Month 10 Day
Date trial data considered complete
2018 Year 03 Month 29 Day
Date analysis concluded
2018 Year 10 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 03 Month 20 Day
Last modified on
2019 Year 04 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018211

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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