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

Faculty of Medicine386 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

386

Conditions

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

Interventions

2.5 units OxytocinDRUG

Administration of 2.5 units of oxytocin after clamping of umbilical cord

10 units OxytocinDRUG

Administration of 10 units of oxytocin after clamping of umbilical cord

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Mulago Hospital Labour Suite Operating Theatres

Kampala, East Africa, Uganda

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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