UMIN-CTR Clinical Trial

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	Obsterics 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
Email	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
Email	shinsuke.tokoro@gmail.com

Sponsor
Institute	Shiga University of Medical Science Department of Obstetrics and Gynecology
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035298