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

Not Applicable

Completed

• Conditions: Adverse Effect of Oxytocic Drugs; Uterine Hemorrhage; Inappropriate Dose of Drug Administered
• Interventions: Drug: 2.5 units Oxytocin; Drug: 10 units Oxytocin

• Registration Number: NCT01726478
• Lead Sponsor: Faculty of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2012-11
• Study First Submitted: 2012-11-03
• Study First Submitted QC: 2012-11-09
• Last Update Submitted: 2012-11-09
• Study First Posted: 2012-11-15
• Last Update Posted: 2012-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 386

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2.5 units oxytocin	2.5 units Oxytocin	Administration of 2.5 units of oxytocin intravenously after clamping of umbilical cord
10 units oxytocin	10 units Oxytocin	Administration of 10 units of oxytocin after clamping of umbilical cord

Primary Outcome Measures

Name	Time	Method
Uterine tone adequacy	2 minutes	The primary outcome was the assessment of either adequate or inadequate Uterine tone at various times after administration of initial oxytocin dose

Secondary Outcome Measures

Name	Time	Method
Intraoperative blood loss	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.

Trial Locations

Locations (1)

Mulago Hospital Labour Suite Operating Theatres; 🇺🇬 Kampala, East Africa, Uganda