UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Predictive factors for umbilical arterial pH in non-elective cesarean delivery: a retrospective study
Title of the study (Brief title)	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	Masashi YOKOSE
Organization	Yokohama City University School of Medicine
Division name	Department of Anaesthesiology and Critical Care Medicine
Address	3-9 Fukuura, Kanazawa-ku, Yokohama, Japan
TEL	(+81)457872800
Email	yokose_p12@yahoo.co.jp

Public contact
Name of contact person	Masashi YOKOSE
Organization	Yokohama City University School of Medicine
Division name	Department of Anaesthesiology and Critical Care Medicine
Address	3-9 Fukuura, Kanazawa-ku, Yokohama, Japan
TEL	(+81)457872800
Homepage URL
Email	yokose_p12@yahoo.co.jp

Sponsor
Institute	Department of Anaesthesiology and Critical Care Medicine, Yokohama City University School of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 12 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026093