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

Memorial University of Newfoundland

Status and phase: Completed; Phase 4

Conditions: Third Stage of Labour

Treatments: Drug: oxytocin

Study type: Interventional

Funder types: Other

Identifiers

NCT00200252

HIC05.79

Details and patient eligibility

About

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.

Enrollment: 300 patients

Sex: Female

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 3 patient groups

group B

Active Comparator group

Description:

women in group B will receive 10 uts oxytocin IM

Treatment:

Drug: oxytocin

group C

Active Comparator group

Description:

women in group C will receive oxytocin 5 uts IV

Treatment:

Drug: oxytocin

group A

Active Comparator group

Description:

women in group A will receive oxytocin 5 uts IM

Treatment:

Drug: oxytocin