UMIN-CTR Clinical Trial

Basic information
Public title	A study on the monitoring of the fetal state during anesthesia.
Acronym	Fetal electrocardiogram
Scientific Title	A study on the monitoring of the fetal state during anesthesia.
Scientific Title:Acronym	Fetal electrocardiogram
Region	Japan

Condition
Condition	Pregnant woman
Classification by specialty	Obsterics and gynecology Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of effects of fetal state during anesthesia by fetal electrocardiogram.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1) Spectral analysis of fetal heart rate variability. 2) High-frequency spectral powers 3) Low-frequency spectral powers
Key secondary outcomes

Base
Study type

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	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Fetal electrocardiogram
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	Not applicable
Gender	Female
Key inclusion criteria	Patients undergoing elective cesarean section
Key exclusion criteria	Patients with massive bleeding is expected.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yoshinobu Kameyama
Organization	Tohoku University Hospital
Division name	Department of Anesthesiology
Zip code
Address	1-1 Seiryoumachi, Aoba-ku, Sendai-shi, Miyagi, Japan
TEL	022-717-7321
Email	y-kameyama@umin.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Yoshinobu Kameyama
Organization	Tohoku University Hospital
Division name	Department of Anesthesiology
Zip code
Address	1-1 Seiryoumachi, Aoba-ku, Sendai-shi, Miyagi, Japan
TEL	022-717-7321
Homepage URL
Email	y-kameyama@umin.ac.jp

Sponsor
Institute	Tohoku University Hospital
Institute
Department

Funding Source
Organization	Department of Anesthesiology,Tohoku University Hospital
Organization
Division
Category of Funding Organization
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	2015 Year 05 Month 07 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	2013 Year 10 Month 23 Day
Date of IRB	2013 Year 10 Month 29 Day
Anticipated trial start date	2015 Year 05 Month 08 Day
Last follow-up date	2019 Year 07 Month 24 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 05 Month 04 Day
Last modified on	2020 Year 03 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020198