UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022737 |
|---|---|
| Receipt number | R000026093 |
| Scientific Title | Predictive factors for umbilical arterial pH in non-elective cesarean delivery: a retrospective study |
| Date of disclosure of the study information | 2016/06/14 |
| Last modified on | 2016/11/14 16:49:05 |
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Basic information
Public title
Predictive factors for umbilical arterial pH in non-elective cesarean delivery: a retrospective study
Acronym
Umbilical arterial pH in emergency cesarean delivery
Scientific Title
Predictive factors for umbilical arterial pH in non-elective cesarean delivery: a retrospective study
Scientific Title:Acronym
Umbilical arterial pH in emergency cesarean delivery
Region
| Japan |
Condition
Condition
parturients who underwent non-elective cesarean section and their fetuses
Classification by specialty
| Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We explore the predictive factors which affect umbilical arterial pH value of patients who underwent the non-elective cesarean delivery.
Basic objectives2
Others
Basic objectives -Others
exploring predictie factors
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
umbilical arterial pH
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Consecutive patients who underwent emergency cesarean section were included.
(from July 1, 2012 to September 30, 2015)
Key exclusion criteria
The following cases were exclued:
The data of umbilical artery pH value was lack
Converted from spinal to general anesthesia
Spinal anesthesia was performed more than twice
Insufficient hemodynamic data during the opetations.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masashi YOKOSE |
Organization
Yokohama City University School of Medicine
Division name
Department of Anaesthesiology and Critical Care Medicine
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Japan
TEL
(+81)457872800
yokose_p12@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masashi YOKOSE |
Organization
Yokohama City University School of Medicine
Division name
Department of Anaesthesiology and Critical Care Medicine
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Japan
TEL
(+81)457872800
Homepage URL
yokose_p12@yahoo.co.jp
Sponsor or person
Institute
Department of Anaesthesiology and Critical Care Medicine, Yokohama City University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
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
| 2016 | Year | 06 | Month | 14 | 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
Completed
Date of protocol fixation
| 2015 | Year | 12 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 31 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
All patients and neonatal data were retrospectively obtained from the medical records.
The folowing twenty one covariates were selected as potential explanatory factors.
Patients fctor:
(1) age; (2) height; (3) weight; (4) American Society of Anesthesiologists Physical Status; (5) twin pregnancy; (6) previous cesarean section; (7) labor; (8) gestational diabetes mellitus; (9) pregnancy induced hypertension
Anesthetic factors:
(10) induction of anesthesia to delivery interval; (11) anesthesia type (general or regional); (12) % change in systolic blood pressure; the dose of (13) ephedrine and/or (14) phenylephrine ; the volume of (15) intraoperative infusion, (16) intraoperative blood loss
Fetal factors:
(17) gestational age , (18) fetal anomalies, (19) estimated fetal body weight; (20) amniotic fluid, (21) non-reassuring fetal status.
Statisitcal analysis: a stepwise multiple regression analysis with Akaike's information criterion
Management information
Registered date
| 2016 | Year | 06 | Month | 14 | Day |
Last modified on
| 2016 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026093
| Research Plan | |
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