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CompletedNCT01726478Updated Nov 15, 2012

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

An interventional study of 2.5 units Oxytocin and 10 units Oxytocin in Adverse Effect of Oxytocic Drugs, Uterine Hemorrhage and Inappropriate Dose of Drug Administered, sponsored by Faculty of Medicine. Completed at 1 site in Uganda. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-11-15.

Sponsored by Faculty of Medicine · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
386
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study 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.

02

Conditions studied

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

Keywords

  • Oxytocin
  • Uterine tone
  • Mulago Hospital
  • Dose
  • Side effects
03

In context

Uterine Hemorrhage

156 studies on the registry are indexed under Uterine Hemorrhage; 19 are open to participants now.

This study's enrollment of 386 is above the median of 96 across 111 interventional studies indexed under Uterine Hemorrhage.

Browse Uterine Hemorrhage studies →

Lead sponsor

This is the only study on the registry with Faculty of Medicine as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
386 participants (actual)

Study arms

  • Active comparator
    2.5 units oxytocin

    Administration of 2.5 units of oxytocin intravenously after clamping of umbilical cord

    Drug: 2.5 units Oxytocin

  • Placebo comparator
    10 units oxytocin

    Administration of 10 units of oxytocin after clamping of umbilical cord

    Drug: 10 units Oxytocin

Interventions

  • Drug2.5 units Oxytocin

    Administration of 2.5 units of oxytocin after clamping of umbilical cord

    Also known as: pitocin

  • Drug10 units Oxytocin

    Administration of 10 units of oxytocin after clamping of umbilical cord

    Also known as: pitocin

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 2 minutes

Secondary outcomes

  1. 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.

    Time frame: 24 hours

07

Study locations

1 site
  • Mulago Hospital Labour Suite Operating Theatres
    Kampala, East Africa +256, Uganda
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 15, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01726478
Lead sponsor
Faculty of Medicine
Responsible party
Faculty of Medicine (Dr Andrew Kintu, Makerere University) — Sponsor-investigator
First posted
Nov 15, 2012
Start date
Feb 2011
Primary completion
Apr 2011
Completion
Apr 2011
Last update
Nov 15, 2012

Study contacts

Andrew Kintu, MBChB
principal investigator · Makerere University College of Health Sciences Department of Anaesthesia

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.

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