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

November 9, 2012 updated by: Faculty of Medicine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

386

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • pitocin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Faculty of Medicine

Investigators

  • Principal Investigator: Andrew Kintu, MBChB, Makerere University College of Health Sciences Department of Anaesthesia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

November 3, 2012

First Submitted That Met QC Criteria

November 9, 2012

First Posted (Estimate)

November 15, 2012

Study Record Updates

Last Update Posted (Estimate)

November 15, 2012

Last Update Submitted That Met QC Criteria

November 9, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OXY168

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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