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

Sponsor

Faculty of Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT01726478

Collaborator

(none)

386

Enrollment

Location

Arms

1.9

Duration (Months)

199.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Adverse Effect of Oxytocic Drugs Uterine Hemorrhage Inappropriate Dose of Drug Administered	Drug: 2.5 units Oxytocin Drug: 10 units Oxytocin	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

386 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Uterotonic Efficacy of Oxytocin 2.5 Versus 10 Units During Caesarean Section at Mulago Hospital; Adouble Blinded Clinical Trial.

Study Start Date :

Feb 1, 2011

Actual Primary Completion Date :

Apr 1, 2011

Actual Study Completion Date :

Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 2.5 units oxytocin Administration of 2.5 units of oxytocin intravenously after clamping of umbilical cord	Drug: 2.5 units Oxytocin Administration of 2.5 units of oxytocin after clamping of umbilical cord Other Names: pitocin
Placebo Comparator: 10 units oxytocin Administration of 10 units of oxytocin after clamping of umbilical cord	Drug: 10 units Oxytocin Administration of 10 units of oxytocin after clamping of umbilical cord Other Names: pitocin

Arm

Intervention/Treatment

Active Comparator: 2.5 units oxytocin

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

Drug: 2.5 units Oxytocin

Administration of 2.5 units of oxytocin after clamping of umbilical cord

Other Names:

pitocin

Placebo Comparator: 10 units oxytocin

Administration of 10 units of oxytocin after clamping of umbilical cord

Drug: 10 units Oxytocin

Administration of 10 units of oxytocin after clamping of umbilical cord

Other Names:

pitocin

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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