UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026390 |
|---|---|
| Receipt number | R000030306 |
| Scientific Title | Study with the muscle hardness meter on objectification of postpartum uterine contraction and its application to obstetric bleeding management |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2017/03/03 19:04:11 |
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Basic information
Public title
Study with the muscle hardness meter on objectification of postpartum uterine contraction and its application to obstetric bleeding management
Acronym
muscle hardness meter and obstetric bleeding
Scientific Title
Study with the muscle hardness meter on objectification of postpartum uterine contraction and its application to obstetric bleeding management
Scientific Title:Acronym
muscle hardness meter and obstetric bleeding
Region
| Japan |
Condition
Condition
pregnant women who received C-section
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
the efficacy of objectification of postpartum uterine contraction with muscle hardness meter in obstetric bleeding management
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the amount of bleeding during and 4 hours after C-section
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
We measure the muscle hardness three consecutive times at corpus and fundus uteri immediately after the baby and palacenta have delivered, and adopt the median value.
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
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Female
Key inclusion criteria
All the pregnant women who underwent elective C-section at our hospital.
Written consent is received from all the opregnant women.
Key exclusion criteria
All the pregnant women judged unsuitable for participation in this research by the doctor in charge.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Imai |
Organization
Nagoya University Graduate School of Medicine
Division name
Obstetrics and Gynecology
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL
052-744-2261
kenchan2@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Imai |
Organization
Nagoya University Graduate School of Medicine
Division name
Obstetrics and Gynecology
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL
052-744-2261
Homepage URL
kenchan2@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Nagoya University
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
| 2017 | Year | 04 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 03 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 03 | Day |
Last modified on
| 2017 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030306
