UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030944 |
|---|---|
| Receipt number | R000035298 |
| Scientific Title | Prospective study on effectiveness of sacral surface therapeutic electrical stimulation for pregnant women during threatened preterm labor |
| Date of disclosure of the study information | 2018/01/25 |
| Last modified on | 2019/07/27 22:52:53 |
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Basic information
Public title
Prospective study on effectiveness of sacral surface therapeutic electrical stimulation for pregnant women during threatened preterm labor
Acronym
Prospective study on therapeutic electrical stimulation for threatened preterm labor
Scientific Title
Prospective study on effectiveness of sacral surface therapeutic electrical stimulation for pregnant women during threatened preterm labor
Scientific Title:Acronym
Prospective study on therapeutic electrical stimulation for threatened preterm labor
Region
| Japan |
Condition
Condition
premature threatened labor
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparing the strength and frequency of uterine contraction, maternal-fetal blood flow, fetal cardiotocogram, and perinatal complications between `conventional therapy` group using conventional tocolytic agents, and `additional sacral surface therapeutic electrical stimulation therapy` group, to evaluate the effectiveness of new therapy for premature threatened labor.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total daily dose of tocolytic agents at the completion of therapy
Key secondary outcomes
blood flow of fetal umbilical cord, estimated fetal weight, resistance of maternal uterine artery, stiffness of uterine cervix and so on
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
conventional therapy
Interventions/Control_2
additional sacral surface therapeutic electrical stimulation
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
pregnant women aged 18 and over with threatened premature labor between 24 weeks and 34 weeks of gestation
Key exclusion criteria
abruption of placenta, prolapse of umbilical cord, non reassuring fetal status, massive genital hemorrhage due to placenta previa, uterine rupture, and other feto-maternal emergent status
Target sample size
172
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinsuke Tokoro |
Organization
Shiga University of Medical Science
Division name
Department of Obstetrics and Gynecology
Zip code
Address
tsukinowa-cho, seta, otsu city, Shiga prefecture
TEL
077-548-2267
shinsuke.tokoro@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinsuke Tokoro |
Organization
Shiga University of Medical Science
Division name
Department of Obstetrics and Gynecology
Zip code
Address
tsukinowa-cho, seta, otsu city, Shiga prefecture
TEL
077-548-2267
Homepage URL
shinsuke.tokoro@gmail.com
Sponsor or person
Institute
Shiga University of Medical Science
Department of Obstetrics and Gynecology
Institute
Department
Personal name
Funding Source
Organization
Shiga University of Medical Science
Department of Obstetrics and Gynecology
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
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | Month | 25 | Day |
Related information
URL releasing protocol
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
Terminated
Date of protocol fixation
| 2018 | Year | 01 | Month | 15 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 23 | Day |
Last modified on
| 2019 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035298
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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