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

Overview

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.

Full Title of Study: “Uterotonic Efficacy of Oxytocin 2.5 Versus 10 Units During Caesarean Section at Mulago Hospital; Adouble Blinded Clinical Trial.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: April 2011

Interventions

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

Arms, Groups and Cohorts

  • Active Comparator: 2.5 units oxytocin
    • Administration of 2.5 units of oxytocin intravenously after clamping of umbilical cord
  • Placebo Comparator: 10 units oxytocin
    • Administration of 10 units of oxytocin after clamping of umbilical cord

Clinical Trial Outcome Measures

Primary 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 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.

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Faculty of Medicine
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Faculty of Medicine, Dr Andrew Kintu – Makerere University
  • Overall Official(s)
    • Andrew Kintu, MBChB, Principal Investigator, Makerere University College of Health Sciences Department of Anaesthesia

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