UMIN-CTR Clinical Trial

Basic information
Public title	Intraoperative hemorrhage after cesarean section with oxytocin infusion variables: a single-center retrospective analysis.
Acronym	Intraoperative hemorrhage after cesarean section with oxytocin infusion variables: a single-center retrospective analysis.
Scientific Title	Intraoperative hemorrhage after cesarean section with oxytocin infusion variables: a single-center retrospective analysis.
Scientific Title:Acronym	Intraoperative hemorrhage after cesarean section with oxytocin infusion variables: a single-center retrospective analysis.
Region	Japan

Condition
Condition	cesarean section
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The amount of intraoperative hemorrhage be affected by different styles of oxytocin infusion.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Intraoperative hemorrhage
Key secondary outcomes	The amount of oxytocin The frequency of oxytocin-related complications

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	80 years-old >=
Gender	Female
Key inclusion criteria	The patient receiving cesarean section
Key exclusion criteria	Allergy to oxytocin
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Takeshi Middle name Last name Murouchi
Organization	Asahi General Hospital
Division name	Department of Anesthesiology
Zip code	289-2511
Address	I-1326 Asahi, Chiba
TEL	0479-63-8111
Email	g-fields@fc4.so-net.ne.jp

Public contact
Name of contact person	1st name Takeshi Middle name Last name Murouchi
Organization	Asahi General Hospital
Division name	Department of Anesthesiology
Zip code	289-2511
Address	I-1326 Asahi, Chiba
TEL	0479-63-8111
Homepage URL
Email	g-fields@fc4.so-net.ne.jp

Sponsor
Institute	Department of Anesthesiology, Asahi General Hospital
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	Asahi General Hospital
Address	I-1326 Asahi, Chiba
Tel	0479-63-8111
Email	g-fields@fc4.so-net.ne.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	2021 Year 02 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://doi.org/10.31487/j.ACR.2021.02.01
Number of participants that the trial has enrolled	174
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2021 Year 08 Month 26 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2021 Year 01 Month 04 Day
Date of IRB	2021 Year 01 Month 19 Day
Anticipated trial start date	2021 Year 02 Month 01 Day
Last follow-up date	2021 Year 06 Month 30 Day
Date of closure to data entry	2021 Year 06 Month 30 Day
Date trial data considered complete	2021 Year 06 Month 30 Day
Date analysis concluded

Other
Other related information	The patient data be collected from medical records and anesthesia records.

Management information
Registered date	2021 Year 01 Month 08 Day
Last modified on	2022 Year 01 Month 09 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049019