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

This study has been completed.
Information provided by (Responsible Party):
Faculty of Medicine, Makerere University Identifier:
First received: November 3, 2012
Last updated: November 9, 2012
Last verified: November 2012
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.

Condition Intervention
Adverse Effect of Oxytocic Drugs
Uterine Hemorrhage
Inappropriate Dose of Drug Administered
Drug: 2.5 units Oxytocin
Drug: 10 units Oxytocin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Uterotonic Efficacy of Oxytocin 2.5 Versus 10 Units During Caesarean Section at Mulago Hospital; Adouble Blinded Clinical Trial.

Resource links provided by NLM:

Further study details as provided by Makerere University:

Primary Outcome Measures:
  • Uterine tone adequacy [ Time Frame: 2 minutes ]
    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 [ Time Frame: 24 hours ]
    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.

Enrollment: 386
Study Start Date: February 2011
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2.5 units oxytocin
Administration of 2.5 units of oxytocin intravenously after clamping of umbilical cord
Drug: 2.5 units Oxytocin
Administration of 2.5 units of oxytocin after clamping of umbilical cord
Other Name: pitocin
Placebo Comparator: 10 units oxytocin
Administration of 10 units of oxytocin after clamping of umbilical cord
Drug: 10 units Oxytocin
Administration of 10 units of oxytocin after clamping of umbilical cord
Other Name: pitocin


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT01726478

Mulago Hospital Labour Suite Operating Theatres
Kampala, East Africa, Uganda, +256
Sponsors and Collaborators
Faculty of Medicine
Principal Investigator: Andrew Kintu, MBChB Makerere University College of Health Sciences Department of Anaesthesia
  More Information

Responsible Party: Faculty of Medicine, Dr Andrew Kintu, Makerere University Identifier: NCT01726478     History of Changes
Other Study ID Numbers: OXY168
Study First Received: November 3, 2012
Last Updated: November 9, 2012

Keywords provided by Makerere University:
Uterine tone
Mulago Hospital
Side effects

Additional relevant MeSH terms:
Uterine Hemorrhage
Pathologic Processes
Uterine Diseases
Genital Diseases, Female
Reproductive Control Agents
Physiological Effects of Drugs processed this record on April 28, 2017