Uterotonic Efficacy of Oxytocin 2.5 Versus 10 Units During Caesarean Section at Mulago Hospital

Uterine Hemorrhage Clinical Trial

Official title:

Uterotonic Efficacy of Oxytocin 2.5 Versus 10 Units During Caesarean Section at Mulago Hospital; Adouble Blinded Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01726478
• Other study ID #: OXY168
• Status: Completed
• Phase: N/A
• First received: November 3, 2012
• Last updated: November 9, 2012
• Start date: February 2011
• Est. completion date: April 2011

Study information

• Verified date: November 2012
• Source: Makerere University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Uganda: National Council for Science and TechnologyUganda: Research Ethics CommitteeUganda: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 386
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adverse Effect of Oxytocic Drugs
• Inappropriate Dose of Drug Administered
• Uterine Hemorrhage

Intervention

Drug:
• 2.5 units Oxytocin
Administration of 2.5 units of oxytocin after clamping of umbilical cord
• 10 units Oxytocin
Administration of 10 units of oxytocin after clamping of umbilical cord

Locations

Country	Name	City	State
Uganda	Mulago Hospital Labour Suite Operating Theatres	Kampala	East Africa

Sponsors (1)

Lead Sponsor	Collaborator
Faculty of Medicine

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2 minutes	Yes
Secondary	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.	24 hours	Yes