UMIN-CTR Clinical Trial

Public title

The effects and side effects of oxytocin: a randomized double-blind comparison of intramyometrial oxytocin and intravenous oxytocin during elective Cesarean section

Acronym

The effects and side effects of oxytocin: a randomized double-blind comparison of intramyometrial oxytocin and intravenous oxytocin during elective Cesarean section

Scientific Title

The effects and side effects of oxytocin: a randomized double-blind comparison of intramyometrial oxytocin and intravenous oxytocin during elective Cesarean section

Scientific Title:Acronym

The effects and side effects of oxytocin: a randomized double-blind comparison of intramyometrial oxytocin and intravenous oxytocin during elective Cesarean section

Region

Japan

Condition

Elective Cesarean section

Classification by specialty

Obstetrics and Gynecology

Anesthesiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Oxytocin is routinely administered during Cesarean section to promote uterine contraction and reduce blood loss from the placental site. When administered as a rapid intravenous (i.v.) bolus, it causes abrupt hypotension, tachycardia and ECG changes and the i.v. administration of 10 units of oxytocin has been reported to cause cardiovascular collapse and death. Although there have been some studies to investigate the better methods of administration, there is only one report about the effects of intramyometrial oxytocin. Our clinical impression has been that the intramyometrial oxytocin, followed by a routine infusion, produces adequate uterine contraction with fewer adverse effects than the i.v. bolus injection. We have designed this randomized double-blind trial to compare the effects and adverse effects of intramyometrial oxytocin with intravenous oxytocin.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The lowest systolic blood pressure and the highest heart rate within ten minute after the administration of oxytocin

Key secondary outcomes

Uterine tone assessed by obstetricians
Blood loss during operation
The rate of patients administered additional uterotonics within 24hour after baby delivery
The adverse effects of oxytocin (nausea, vomiting, facial flushing)

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Maneuver

Interventions/Control_1

Immediately after delivery of the baby and cord clamping, the obstetrician gives a 2mL intramyometrial test drug (0.07unit/kg oxytocin plus normal saline). At the same time, an anesthesiologist gives a 10mL test drug (normal saline) intravenously over 30seconds.

Interventions/Control_2

Immediately after delivery of the baby and cord clamping, the obstetrician gives a 2mL intramyometrial test drug (normal saline). At the same time, an anesthesiologist gives a 10mL test drug (0.07unit/kg oxytocin plus normal saline) intravenously over 30seconds.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

45

years-old

>

Gender

Female

Key inclusion criteria

ASA physical status 1 or 2, gestational age of over 36 weeks, elective Cesarean section

Key exclusion criteria

More than two previous Cesarean sections, previous post-partum hemorrhage, known placenta previa, twin pregnancy, polyhydramnios, pregnancy induced hypertension

Target sample size

40

Name of lead principal investigator

1st name
Middle name
Last name	Shigehito Sato

Organization

Hamamatsu University School of Medicine

Division name

Department of Anesthesiology and Intensive Care Medicine

Zip code

Address

1-20-1 Handayama Higashi-ku Hamamatsu-shi

TEL

Email

Name of contact person

1st name
Middle name
Last name	Chieko Akinaga

Organization

Hamamatsu University School of Medicine

Division name

Department of Anesthesiology and Intensive Care Medicine

Zip code

Address

1-20-1 Handayama Higashi-ku Hamamatsu-shi

TEL

053-435-2286

Homepage URL

Email

Institute

Department of Anesthesiology and Intensive Care

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

浜松医科大学医学部附属病院

Date of disclosure of the study information

2012

Year

03

Month

28

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2012

Year

02

Month

01

Day

Date of IRB

Anticipated trial start date

2012

Year

04

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

03

Month

27

Day

Last modified on

2013

Year

01

Month

04

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008709