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

NCT ID: NCT01726478

Last Updated: 2012-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

386 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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

Keywords

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Oxytocin Uterine tone Mulago Hospital Dose Side effects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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2.5 units oxytocin

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

Group Type ACTIVE_COMPARATOR

2.5 units Oxytocin

Intervention Type DRUG

Administration of 2.5 units of oxytocin after clamping of umbilical cord

10 units oxytocin

Administration of 10 units of oxytocin after clamping of umbilical cord

Group Type PLACEBO_COMPARATOR

10 units Oxytocin

Intervention Type DRUG

Administration of 10 units of oxytocin after clamping of umbilical cord

Interventions

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2.5 units Oxytocin

Administration of 2.5 units of oxytocin after clamping of umbilical cord

Intervention Type DRUG

10 units Oxytocin

Administration of 10 units of oxytocin after clamping of umbilical cord

Intervention Type DRUG

Other Intervention Names

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pitocin pitocin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Faculty of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Faculty of Medicine

Dr Andrew Kintu

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Andrew Kintu, MBChB

Role: PRINCIPAL_INVESTIGATOR

Makerere University College of Health Sciences Department of Anaesthesia

Locations

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Mulago Hospital Labour Suite Operating Theatres

Kampala, East Africa, Uganda

Site Status

Countries

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Uganda

Other Identifiers

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OXY168

Identifier Type: -

Identifier Source: org_study_id