Oxytocin Administration in the Third Stage of Labour - A Study of Appropriate Route and Dose

Phase 4

Completed

• Conditions: Third Stage of Labour
• Interventions: Drug: oxytocin

• Registration Number: NCT00200252
• Lead Sponsor: Memorial University of Newfoundland

Brief Summary

Mothers are given the medication oxytocin after birth to help the uterus (womb) contract and therefore reduce blood loss. In Canada, oxytocin is given either into the muscle of the thigh or into a vein. However, it is not known which route is better.This study will test which dose and route of oxytocin is best in reducing blood loss following vaginal delivery.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-20
• Study Completion: 2007-07
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-08
• Last Update Posted: 2012-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

• women 19 years and older
• singleton pregnancy
• 32 weeks gestation
• spontaneous vaginal delivery

Exclusion Criteria

• previous postpartum hemorrhage
• placenta previa
• grand multiparity (>4)
• anticoagulation therapy
• delivery prior to 32 weeks gestation
• operative vaginal delivery
• antepartum hemorrhage > 20 weeks
• hemoglobin <10g/dL
• multiple gestation
• intrauterine death

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
group A	oxytocin	women in group A will receive oxytocin 5 uts IM
group B	oxytocin	women in group B will receive 10 uts oxytocin IM
group C	oxytocin	women in group C will receive oxytocin 5 uts IV

Primary Outcome Measures

Name	Time	Method
change in hematocrit

Secondary Outcome Measures

Name	Time	Method
estimated blood loss
postpartum hemorrhage (estimated blood loss > 500cc)
severe postpartum hemorrhage (estimated blood loss > 1000cc)
incidence of hypotension
length of third stage of labour
need for blood transfusion
incidence of retained placenta
need for dilatation and curettage
need for hysterectomy
need for additional oxytocics after delivery
postpartum antibiotic use
maternal satisfaction
bleeding needing readmission

Trial Locations

Locations (1)

Women's Health Centre, Eastern Health; 🇨🇦 St. John's, Newfoundland and Labrador, Canada