UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016592 |
|---|---|
| Receipt number | R000019253 |
| Scientific Title | The study of the measurement of fetal heart rate by using ultrasonography. |
| Date of disclosure of the study information | 2015/02/20 |
| Last modified on | 2017/04/18 09:34:51 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The study of the measurement of fetal heart rate by using ultrasonography.
Acronym
The study of fetal heart rate
Scientific Title
The study of the measurement of fetal heart rate by using ultrasonography.
Scientific Title:Acronym
The study of fetal heart rate
Region
| Japan |
Condition
Condition
pregnant women
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assessment of the pregnancy outcome and fetal mortality by measurement of the fetal heart rate.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pregnancy outcome, abortion rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Measurement of fetal heart rate counts for fifty pregnant women.
Interventions/Control_2
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
| 16 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Female
Key inclusion criteria
pregnant women
Key exclusion criteria
When an agreement for the declaration of consent is not provided.
When a pregnant women has a mental disorder.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Susumu Murata |
Organization
Kawasaki Medical School
Division name
Obstetrics and Gynecology
Zip code
Address
577 matsushima, kurashiki, Okayama
TEL
086-462-1111
smurata@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Susumu Murata |
Organization
Kawasaki Medical School
Division name
Obstetrics and Gynecology
Zip code
Address
577 matusshima, Kurashiki, Okayama
TEL
086-462-1111
Homepage URL
smurata@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Medical School
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
| 2015 | Year | 02 | Month | 20 | 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
| 2015 | Year | 02 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2017 | Year | 04 | Month | 18 | Day |
Date of closure to data entry
| 2017 | Year | 04 | Month | 18 | Day |
Date trial data considered complete
| 2017 | Year | 04 | Month | 18 | Day |
Date analysis concluded
| 2017 | Year | 04 | Month | 18 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 02 | Month | 20 | Day |
Last modified on
| 2017 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019253
| Research Plan | |
|---|---|
| Registered date | File name |
| 2017/02/21 | 研究実施計画書平成28年6月改訂版ver1.1.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
