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

Phase 4CompletedNCT00200252

Memorial University of Newfoundland300 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

300

Conditions

Third Stage of Labour

Interventions

oxytocinDRUG

Eligibility

Sex: FEMALEMin age: 19 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Women's Health Centre, Eastern Health

St. John's, Newfoundland and Labrador, Canada

Outcomes

Primary Outcomes

change in hematocrit

Secondary Outcomes

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

Data from ClinicalTrials.gov

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