The aim of this study was to investigate the comparison efficacy of “rule of threes” algorithm with Williams’s guideline in uterine tone evaluations as well as side effects of each approach in the women undergoing to elective cesarean delivery.
Design
In this triple blind study a total of 110 candidate patients for elective cesarean delivery were randomly divided into two groups. The surgeon, analyzer and the person who administrated drug were blind for groups.
Settings and conduct
Background: 110 patients undergoing elective cesarean section
Location: Imam Hossein Hospital (2016- 2016)
Methods: This prospective, triple-blind, prospective study was performed on 55 patients with ASA I II and undergoing cesarean section. Patients were randomly divided into two groups according to the oxytocin method.
Grouping: Group 1 received oxytocin by the Rule of Threes method and group two received oxytocin based on the Williams line. Oxytocin consumption and hemodynamic parameters were recorded and compared in both groups.
Conclusion: In both methods there were no abnormal changes in hemodynamics and other complications associated with high doses of oxytocin.
Blindness: Three Blind Strains (Patient-Researcher-Data Controller Team)
Participants/Inclusion and exclusion criteria
Inclusion criteria: American Society of Anesthesiologists (ASA) physical status, first to third candidate elective Cesarean delivery
Exclusion criteria: labor pain, presence of fetal risk factors for atony, presence of maternal risk factor for atony, diabetes melitus, uterine fibroma, thrombocytopenia< 100000/microliter
Intervention groups
group 1 was received oxytocin using Rule of Threes approach.
group 2 was received oxytocin using William’s guideline.
Main outcome variables
The mean level of oxytocin dose in both groups
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120430009593N13
Registration date:2020-03-09, 1398/12/19
Registration timing:retrospective
Last update:2020-03-09, 1398/12/19
Update count:0
Registration date
2020-03-09, 1398/12/19
Registrant information
Name
Elham Memary
Name of organization / entity
Shahid Beheshti University
Country
Iran (Islamic Republic of)
Phone
+98 21 7755 8082
Email address
drmemary@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
2016-09-22, 1395/07/01
Actual recruitment end date
2018-11-06, 1397/08/15
Trial completion date
2018-11-06, 1397/08/15
Scientific title
Evaluation and comparison of administrated oxytocin dose based on “rule of threes” algorithm with Williams guideline in the elective cesarean delivery
Public title
Determination of oxytocin dose based on “rule of threes” algorithm and Williams guideline in the elective cesarean delivery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The women who undergoing to the first to third elective Cesarean delivery with spinal anesthetic technique
American Society of Anesthesiologists (ASA) physical status I–II
Exclusion criteria:
Labor pain
The presence of maternal risk factors for uterine atony
The presence of fetal risk factors for uterine atony
Diabetes melitus
Thrombocytopenia<100000 per microliter
Uterine fibroma
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Data and Safety Monitoring Board
Sample size
Target sample size:
110
Actual sample size reached:
110
Randomization (investigator's opinion)
Randomized
Randomization description
• Randomization method: Simple randomization
• Randomization Unit: based on patient
• Randomization Tool: Random Number Table - block stratified randomization software wnidow version 6.0 Using this software, a random number table is created and the sample list is divided into two groups of 30 each.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Participants enter two treatment groups based on a random number table. There is also a ready-made package available to the physician and nurse, including 55 packages of the first and 55 packages of the second drug. The data monitoring committee was also blinded of the grouping
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The ethical commite of Shahid Beheshti Medical University
Street address
Shahid Beheshti University of Medical Sciences, Shahid Erabi St, Ebne Yaman St, Shahid Chamran Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2018-07-10, 1397/04/19
Ethics committee reference number
IR.SBMU.MSP.REC.1397.462
Health conditions studied
1
Description of health condition studied
Elective cesarean delivery
ICD-10 code
O82
ICD-10 code description
Encounter for cesarean delivery without indication
Primary outcomes
1
Description
creating of adequate uterine tonicity
Timepoint
at 3, 6, 9, 12, and 15 min after onset of surgery
Method of measurement
Uterine tonicity was evaluated as atonic, partial tonicity, adequate tonicity, well contracted and very well contracted by obstetrician.
Secondary outcomes
1
Description
The time of administrated oxytocin to obtain adequate tonicity
Timepoint
At 3, 6, 9, 12, and 15 minute after onset of cesarean
Method of measurement
The mean administrated oxytocin
Intervention groups
1
Description
Intervention group:The patients in “rule of threes” algorithm group received Bolus oxytocin 3IU/3ml (0.9% saline) . At 3 and 6 min, an “inadequate” uterine tone assessment resulted in repeated bolus administration of oxytocin . At 9 min, an “inadequate” uterine tone assessment resulted in intramuscular injection of methylergonovine (0.2 mg /ml). At 15 min, inadequate uterine tone assessment resulted in administration of misoprostol 600 µg buccaly.
Category
Treatment - Drugs
2
Description
Intervention group: The William`s group received Bolus oxytocin 3 ml 0.09 % saline and then oxytocin infusion by pump at 15 ml/min until adequate uterine tonocity achieved then followed by 1-2 ml/min until patient entrance to recovery. At delivery, 3, 6, 9, 12, and 15 min postpartum, the patients were asked if they had flushing, nausea, chest pain, headache, ECG changes such as ST-T wave changes and other complaints. To nausea prophylaxis, all patients received ondansetron 4 mg intravenously after the delivery. Total administrated oxcytocin for both groups was finally recorded and then compared.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
بیمارستان امام حسین
Full name of responsible person
الهام معماری
Street address
تهران، خیابان شهید مدنی، بیمارستان امام حسین، بخش بی هوشی
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7756 7840
Email
drmemary@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
University Blvd, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9781
Email
mpajouhesh@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Elham Memari
Position
Associated Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
University Blvd, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 77557840
Email
drmemary@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Yousef Ghorbani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Velenjak, University Blvd
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9781
Email
mpajouhesh@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Elham Memray
Position
Asscocited Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
University Blvd, Velenjek
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9781
Email
mpajouhesh@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Some of data can be shared.
When the data will become available and for how long
Get 6 months after publishing
To whom data/document is available
محققین دانشگاهی و کلینیسن ها
Under which criteria data/document could be used
For more research
From where data/document is obtainable
Via email: y.ghorbani.m@gmail.com
What processes are involved for a request to access data/document