UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study with the muscle hardness meter on objectification of postpartum uterine contraction and its application to obstetric bleeding management
Title of the study (Brief title)	muscle hardness meter and obstetric bleeding
Region	Japan

Condition
Condition	pregnant women who received C-section
Classification by specialty	Obsterics 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	Kenji Imai
Organization	Nagoya University Graduate School of Medicine
Division name	Obstetrics and Gynecology
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL	052-744-2261
Email	kenchan2@med.nagoya-u.ac.jp

Public contact
Name of contact person	Kenji Imai
Organization	Nagoya University Graduate School of Medicine
Division name	Obstetrics and Gynecology
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL	052-744-2261
Homepage URL
Email	kenchan2@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University
Institute
Department

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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 03 Month 03 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030306