UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025247
Receipt number R000029041
Scientific Title The effect of sacral surface electrical stimulation for threatened premature delivery:retrospective study
Date of disclosure of the study information 2016/12/13
Last modified on 2023/03/18 10:11:55

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Basic information

Public title

The effect of sacral surface electrical stimulation for threatened premature delivery:retrospective study

Acronym

The effect of sacral surface electrical stimulation for threatened premature delivery:retrospective study

Scientific Title

The effect of sacral surface electrical stimulation for threatened premature delivery:retrospective study

Scientific Title:Acronym

The effect of sacral surface electrical stimulation for threatened premature delivery:retrospective study

Region

Japan


Condition

Condition

Threatened premature delivery

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

safety

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

fetal flow velocity
maternal flow velocity
fetal heart rate monitoring
pregnancy outcome

Key secondary outcomes

The effect of tocolytic
uterine contraction frequency


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Sacral surface electrical stimulation

5 sec stimulation 5 sec pause, for gauges 15 minutes repeatedly after tocolysis.

Interventions/Control_2

Non-Sacral surface 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


Not applicable

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

Threatened premature labor

Key exclusion criteria

Placental abruption
Umbilical cord prolapse
Fetal placental insufficiency
Placenta previa
Uterine rupture

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Daisuke
Middle name
Last name Katsutra

Organization

Shiga university of medical science

Division name

Obstetrics and gynecology

Zip code

520-2192

Address

Tsukinowa-cho, otsu, shiga

TEL

0775482267

Email

katsuo14@belle.shiga-med.ac.jp


Public contact

Name of contact person

1st name Daisuke
Middle name
Last name Katsutra

Organization

Shiga university of medical science

Division name

Obstetrics and gynecology

Zip code

520-2192

Address

Tsukinowa-cho, otsu, shiga

TEL

0775482267

Homepage URL


Email

katsuo14@belle.shiga-med.ac.jp


Sponsor or person

Institute

Shiga university of medical science

Institute

Department

Personal name



Funding Source

Organization

Shiga university of medical science

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

Shiga university of medical science

Address

Tsukinowa-cho, otsu, shiga

Tel

0775482267

Email

katsuo14@belle.shiga-med.ac.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



Other administrative information

Date of disclosure of the study information

2016 Year 12 Month 13 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

10

Results

Ss-TES is safe during pregnancy.

Results date posted

2021 Year 06 Month 17 Day

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

Completed

Date of protocol fixation

2016 Year 02 Month 16 Day

Date of IRB

2016 Year 01 Month 26 Day

Anticipated trial start date

2016 Year 12 Month 13 Day

Last follow-up date

2017 Year 12 Month 13 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Ss-TES may be useful for not only threatened premature labor but also fetal growth restriction and pregnancy-related low back and pubic bone pain.


Management information

Registered date

2016 Year 12 Month 13 Day

Last modified on

2023 Year 03 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029041


Research Plan
Registered date File name
2018/04/17 study protocol 2.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name