UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042952
Receipt number R000049019
Scientific Title Intraoperative hemorrhage after cesarean section with oxytocin infusion variables: a single-center retrospective analysis.
Date of disclosure of the study information 2021/02/01
Last modified on 2022/01/09 09:09:24

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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

Obstetrics 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 or person

Institute

Department of Anesthesiology,
Asahi General Hospital

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049019


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name