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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Faculty of Medicine, Makerere University
ClinicalTrials.gov Identifier:
NCT01726478
First received: November 3, 2012
Last updated: November 9, 2012
Last verified: November 2012
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

Drug Information available for: Oxytocin
U.S. FDA Resources

Further study details as provided by Makerere University:

Primary Outcome Measures:
  • Uterine tone adequacy [ Time Frame: 2 minutes ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01726478

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

No publications provided

Responsible Party: Faculty of Medicine, Dr Andrew Kintu, Makerere University
ClinicalTrials.gov Identifier: NCT01726478     History of Changes
Other Study ID Numbers: OXY168
Study First Received: November 3, 2012
Last Updated: November 9, 2012
Health Authority: Uganda: National Council for Science and Technology
Uganda: Research Ethics Committee
Uganda: Ministry of Health

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

Additional relevant MeSH terms:
Hemorrhage
Uterine Hemorrhage
Pathologic Processes
Uterine Diseases
Genital Diseases, Female
Oxytocin
 Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013