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

Faculty of Medicine

Status: Completed

Conditions: Inappropriate Dose of Drug Administered; Uterine Hemorrhage; Adverse Effect of Oxytocic Drugs

Treatments: Drug: 10 units Oxytocin; Drug: 2.5 units Oxytocin

Study type: Interventional

Funder types: Other

Identifiers

NCT01726478

OXY168

Details and patient eligibility

About

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.

Enrollment: 386 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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386 participants in 2 patient groups, including a placebo group

2.5 units oxytocin

Active Comparator group

Description:

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

Treatment:

Drug: 2.5 units Oxytocin

10 units oxytocin

Placebo Comparator group

Description:

Administration of 10 units of oxytocin after clamping of umbilical cord

Treatment:

Drug: 10 units Oxytocin