Back to resultsUterotonic Efficacy of Oxytocin 2.5 Versus 10 Units During Caesarean Section at Mulago Hospital
Primary Purpose
Adverse Effect of Oxytocic Drugs, Uterine Hemorrhage, Inappropriate Dose of Drug Administered
Status
Completed
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
2.5 units Oxytocin
10 units Oxytocin
Sponsored by
About this trial
This is an interventional treatment trial for Adverse Effect of Oxytocic Drugs focused on measuring Oxytocin, Uterine tone, Mulago Hospital, Dose, Side effects
Eligibility Criteria
Inclusion Criteria:
- ASA I (Healthy patient with no systemic disease) or II ( mild to moderate systemic disease)
- Age between 18 to 40 years
- Singleton pregnancies
Exclusion Criteria:
• Allergy to oxytocin
- Ruptured uterus
- Significant obstetric disease (including Pregnancy induced Hypertension, Eclampsia,)
- Known risk factors for postpartum haemorrhage or uterine atony
- Inherited or acquired coagulation disorder
- History of post partum haemorrhage
Sites / Locations
- Mulago Hospital Labour Suite Operating Theatres
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
2.5 units oxytocin
10 units oxytocin
Arm Description
Administration of 2.5 units of oxytocin intravenously after clamping of umbilical cord
Administration of 10 units of oxytocin after clamping of umbilical cord
Outcomes
Primary Outcome Measures
Uterine tone adequacy
The primary outcome was the assessment of either adequate or inadequate Uterine tone at various times after administration of initial oxytocin dose
Secondary Outcome Measures
Intraoperative blood loss
Blood loss was estimated by measuring the amount in the suction bottles and weighing of the mops. The patients were followed up for any occurrence of postpartum haemorrhage for the next 24 hours after surgery.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01726478
Brief Title
Uterotonic Efficacy of Oxytocin 2.5 Versus 10 Units During Caesarean Section at Mulago Hospital
Official Title
Uterotonic Efficacy of Oxytocin 2.5 Versus 10 Units During Caesarean Section at Mulago Hospital; Adouble Blinded Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Faculty of Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of the study was to determine whether 2.5 international units of oxytocin gives adequate uterine tone and is safe as compared to 10 international units of oxytocin following caesarean section delivery at Mulago hospital.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adverse Effect of Oxytocic Drugs, Uterine Hemorrhage, Inappropriate Dose of Drug Administered
Keywords
Oxytocin, Uterine tone, Mulago Hospital, Dose, Side effects
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
386 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2.5 units oxytocin
Arm Type
Active Comparator
Arm Description
Administration of 2.5 units of oxytocin intravenously after clamping of umbilical cord
Arm Title
10 units oxytocin
Arm Type
Placebo Comparator
Arm Description
Administration of 10 units of oxytocin after clamping of umbilical cord
Intervention Type
Drug
Intervention Name(s)
2.5 units Oxytocin
Other Intervention Name(s)
pitocin
Intervention Description
Administration of 2.5 units of oxytocin after clamping of umbilical cord
Intervention Type
Drug
Intervention Name(s)
10 units Oxytocin
Other Intervention Name(s)
pitocin
Intervention Description
Administration of 10 units of oxytocin after clamping of umbilical cord
Primary Outcome Measure Information:
Title
Uterine tone adequacy
Description
The primary outcome was the assessment of either adequate or inadequate Uterine tone at various times after administration of initial oxytocin dose
Time Frame
2 minutes
Secondary Outcome Measure Information:
Title
Intraoperative blood loss
Description
Blood loss was estimated by measuring the amount in the suction bottles and weighing of the mops. The patients were followed up for any occurrence of postpartum haemorrhage for the next 24 hours after surgery.
Time Frame
24 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
ASA I (Healthy patient with no systemic disease) or II ( mild to moderate systemic disease)
Age between 18 to 40 years
Singleton pregnancies
Exclusion Criteria:
• Allergy to oxytocin
Ruptured uterus
Significant obstetric disease (including Pregnancy induced Hypertension, Eclampsia,)
Known risk factors for postpartum haemorrhage or uterine atony
Inherited or acquired coagulation disorder
History of post partum haemorrhage
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Kintu, MBChB
Organizational Affiliation
Makerere University College of Health Sciences Department of Anaesthesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mulago Hospital Labour Suite Operating Theatres
City
Kampala
State/Province
East Africa
ZIP/Postal Code
+256
Country
Uganda
12. IPD Sharing Statement
Learn more about this trial
Uterotonic Efficacy of Oxytocin 2.5 Versus 10 Units During Caesarean Section at Mulago Hospital
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