Protocol summary

Summary
The purpose of this study is comparison the effects of oxytocin and methylergonovine in caesarean section under spinal anesthesia. This study is designed as a randomized, prospective, interventional and single blind clinical trial. The study population is all the parturients who are candidate for elective caesarean section under spinal anesthesia. Inclusion criteria consist of: Elective caesarean section . Exclusion criteria consist of: Positive history of cardiovascular disease; Positive history of preeclampsia; Emergent caesarean section; Factors increasing risk of uterine atony . In this study 80 patients are selected and 40 patients in one groups are considered. One group of patients is received 0.2 mg methylergonovine in 1 liter isotonic serum infused after delivery of fetus . Another group of patients is received 30 unit oxytocin in 1 liter isotonic serum infused after delivery of fetus. All the patients after spinal anesthesia in supine position will be monitored and systolic blood pressure; diastolic blood pressure; heart rate and mean arterial blood pressure are recorded in minutes 1,3,5 after spinal anesthesia .Also systolic blood pressure; diastolic blood pressure; heart rate and mean arterial blood pressure are recorded in minutes 1,3,5,10,15,20 after drug administration. Amount of bleeding are estimated by volume of bottle of suctioning apparatus and field of surgery. Hemodynamic parameters are recorded in minutes 5,10,15,20,30 in recovery room.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201207055751N3
Registration date: 2012-07-19, 1391/04/29
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-07-19, 1391/04/29
Registrant information
Name
Abdolrasoul Anvaripour
Name of organization / entity
Bushehr University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 77 1252 6801
Email address
anvari@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Bushehr University of Medical Sciences
Expected recruitment start date
2012-06-21, 1391/04/01
Expected recruitment end date
2012-07-31, 1391/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effects of Oxytocin and Methylergonovine in elective caesarean section under spinal anesthesia
Public title
Comparison the effects of uterotonic constrictors in caesarean section under spinal anesthesia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria consist of: Elective caesarean section Exclusion criteria consist of: positive history of cardiovascular disease; positive history of preeclampsia; emergent caesarean section; factors increasing risk of uterine atony
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Bushehr University of Medical Sciences
Street address
Bahmani; pardis site;Bushehr University of Medical Sciences
City
Bushehr
Postal code
Approval date
2012-04-11, 1391/01/23
Ethics committee reference number
5351

Health conditions studied

1

Description of health condition studied
Caesarean section
ICD-10 code
082.9
ICD-10 code description
Delivery by caesarean section, unspecified

Primary outcomes

1

Description
Systolic Blood Pressure
Timepoint
In minutes 1,3,5 after spinal anesthesia and in minutes 1,3,5,10,15,20 after drug administration
Method of measurement
Non Invasive Blood Pressure Monitoring

2

Description
Diastolic Blood Pressure
Timepoint
In minutes 1,3,5 after spinal anesthesia and in minutes 1,3,5,10,15,20 after drug administration
Method of measurement
NonInvasive Blood Pressure Monitoring

3

Description
Heart Rate
Timepoint
In minutes 1,3,5 after spinal anesthesia and in minutes 1,3,5,10,15,20 after drug administration
Method of measurement
Non Invasive Blood Pressure Monitoring

4

Description
Mean Arterial Blood Pressure
Timepoint
In minutes 1,3,5 after spinal anesthesia and in minutes 1,3,5,10,15,20 after drug administration
Method of measurement
Non Invasive Blood Pressure Monitoring

Secondary outcomes

1

Description
َAmount of bleeding after drug administration
Timepoint
In operation room and recovery room
Method of measurement
Suctioned blood volume in bottle and field of surgery

2

Description
Time of uterine atony
Timepoint
After fetus delivery
Method of measurement
Taking the time of delivery of fetus up to uterine contraction

Intervention groups

1

Description
Intervention Name: Methylergonovine Intervention Description: After fetus delivery , 0.2mg Methylergonovine in 1 liter isotonic serum in case group will be infusion
Category
Treatment - Drugs

2

Description
In control group: Oxytocin 30 unit in one liter isotonic serum will be infused after fetus delivery
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Bentolhoda Hospital
Full name of responsible person
Abdolrasoul Anvaripour
Street address
Bentolhoda Hospital; Moalem Street
City
Bushehr

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Mahnoosh Khakzad
Street address
Bahmani; Pardis Site; Bushehr University of Medical Sciences
City
Bushehr
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bushehr University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Abdolrasoul Anvaripour
Position
Assistant Prifessor of Cardiac Anesthesiology
Other areas of specialty/work
Street address
Bentolhoda Hospital; Moalem Street
City
Bushehr
Postal code
Phone
+98 77 1252 6802
Fax
Email
anvari@bpums.ac.ira.anvari.p@hotmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Abdolrasoul Anvaripour
Position
Assistant Professor of Cardiac Anesthesiology
Other areas of specialty/work
Street address
Bentolhoda Hospital; Moalem Street
City
Bushehr
Postal code
Phone
+98 77 1252 6802
Fax
Email
Anvari@bpums.ac.irA.Anvari.P@hotmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Abdolrasoul Anvaripour
Position
Assistant Professor of Cardiac Anesthesiology
Other areas of specialty/work
Street address
Bentolhoda Hospital; Moale Street
City
Bushehr
Postal code
Phone
+98 77 1252 6802
Fax
Email
anvari@bpums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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