UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016853 |
|---|---|
| Receipt number | 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 | 2023/08/07 08:19:25 |
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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
| Obstetrics 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)
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
kato-s@ncchd.go.jp
Sponsor or person
Institute
National Center for Child Health and Development
Institute
Department
Personal name
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
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
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/37539946/, https://obgyn.onlinelibrary.wiley.com/doi/10.1111/jog.157
Number of participants that the trial has enrolled
624
Results
Among 624 randomly assigned women, 599 completed the study between February 2015 and August 2016. The incidence of preterm birth in the intervention and control groups was 4.2% (13/306) and 5.1% (15/293), respectively. There were no significant differences regarding any secondary outcomes, including obstetric outcomes and physical/mental indicators, during pregnancy.
Results date posted
| 2023 | Year | 08 | Month | 07 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Under review
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
Main results already published
Date of protocol fixation
| 2015 | Year | 03 | Month | 06 | Day |
Date of IRB
| 2014 | Year | 09 | Month | 24 | Day |
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
| 2023 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018211
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| Registered date | File name |
| Research case data | |
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