NCT01726478

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
386

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 3, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 15, 2012

Completed
Last Updated

November 15, 2012

Status Verified

November 1, 2012

Enrollment Period

2 months

First QC Date

November 3, 2012

Last Update Submit

November 9, 2012

Conditions

Adverse Effect of Oxytocic DrugsUterine HemorrhageInappropriate Dose of Drug Administered

Keywords

OxytocinUterine toneMulago HospitalDoseSide effects

Outcome Measures

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

    2 minutes

Secondary Outcomes (1)

  • Intraoperative blood loss

    24 hours

Study Arms (2)

2.5 units oxytocin

ACTIVE COMPARATOR

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

Drug: 2.5 units Oxytocin

10 units oxytocin

PLACEBO COMPARATOR

Administration of 10 units of oxytocin after clamping of umbilical cord

Drug: 10 units Oxytocin

Interventions

2.5 units OxytocinDRUG

Administration of 2.5 units of oxytocin after clamping of umbilical cord

Also known as: pitocin
2.5 units oxytocin
10 units OxytocinDRUG

Administration of 10 units of oxytocin after clamping of umbilical cord

Also known as: pitocin
10 units oxytocin

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • ASA I (Healthy patient with no systemic disease) or II ( mild to moderate systemic disease)
  • Age between 18 to 40 years
  • Singleton pregnancies

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mulago Hospital Labour Suite Operating Theatres

Kampala, East Africa, +256, Uganda

Location

MeSH Terms

Conditions

Uterine Hemorrhage

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Uterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Andrew Kintu, MBChB

    Makerere University College of Health Sciences Department of Anaesthesia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr Andrew Kintu

Study Record Dates

First Submitted

November 3, 2012

First Posted

November 15, 2012

Study Start

February 1, 2011

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

November 15, 2012

Record last verified: 2012-11

Locations

UG(1)