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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000035832
Receipt No. R000040284
Scientific Title The prospective observational study about respiratory depression after caesarean section with spinal morphine.
Date of disclosure of the study information 2019/04/01
Last modified on 2020/08/31

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Basic information
Public title The prospective observational study about respiratory depression after caesarean section with spinal morphine.
Acronym Respiratory depression after caesarean section
Scientific Title The prospective observational study about respiratory depression after caesarean section with spinal morphine.
Scientific Title:Acronym Respiratory depression after caesarean section
Region
Japan

Condition
Condition patients undergoing caesarean section under the spinal anesthesia technique
Classification by specialty
Obsterics and gynecology Anesthesiology Operative medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to assess the rate of cumulative bradyapnea time (total bradyapnea time/total monitoring time) and its related factors
to evaluate the time to first bradyapnea event,the incidence of bradyapnea and its related factors, the incidence of hypoxemia and its related factors, and the occurrence of clinically relevant episodes of respiratory depression.

Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes to assess the rate of cumulative bradyapnea time (total bradyapnea time/total monitoring time) and its related factors
Key secondary outcomes to evaluate 1) the time to first bradyapnea event, 2) the incidence of bradyapnea and its related factors, 3) the incidence of hypoxemia and its related factors, and 4) the occurrence of clinically relevant episodes of respiratory depression.


Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 Women aged more than or equal to20-years-old who were undergoing cesarean delivery performed between 0700 to 2000 hours under spinal anesthesia from April 2019 to March 2020
Key exclusion criteria patients with psychiatric disease and neuromuscular disease
patients who did not provide written informed consent
patients who received other than single-shot spinal anesthesia (multiple administrations of spinal anesthesia, epidural anesthesia, combined spinal-epidural anesthesia and general anesthesia)
patients who underwent cesarean delivery following epidural labor
patients who required additional sedatives and analgesics intraoperatively
Women who received oxygen administration postoperatively, cases which had missing data about patients demographics and respiratory monitoring, and cases which performed respiratory monitoring within 6 hours were excluded from data analysis.
Target sample size 153

Research contact person
Name of lead principal investigator
1st name Mitsuru
Middle name
Last name Ida
Organization Nara Medical University
Division name Anesthesiology
Zip code 634-8521
Address Shijo-machi
TEL 0744-22-3051
Email nwnh0131@yahoo.co.jp

Public contact
Name of contact person
1st name Mitsuru
Middle name
Last name Ida
Organization Nara Medical University
Division name Anesthesiology
Zip code 634-8521
Address Shijo-machi
TEL 0744-22-3051
Homepage URL
Email nwnh0131@yahoo.co.jp

Sponsor
Institute Nara Medical University
Institute
Department

Funding Source
Organization none
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 Nara Medical University
Address 840 Shijo
Tel 09079627114
Email nwnh0131@yahoo.co.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
2019 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 No longer recruiting
Date of protocol fixation
2019 Year 03 Month 20 Day
Date of IRB
2019 Year 02 Month 18 Day
Anticipated trial start date
2019 Year 04 Month 01 Day
Last follow-up date
2020 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2019 Year 02 Month 10 Day
Last modified on
2020 Year 08 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040284

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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