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

This study has been completed.
Sponsor:
Information provided by:
Memorial University of Newfoundland
ClinicalTrials.gov Identifier:
NCT00200252
First received: September 12, 2005
Last updated: November 8, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Third Stage of Labour
Drug: oxytocin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intramuscular Versus Intravascular Oxytocin for the Third Stage of Labour

Resource links provided by NLM:


Further study details as provided by Memorial University of Newfoundland:

Primary Outcome Measures:
  • change in hematocrit

Secondary Outcome Measures:
  • 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

Enrollment: 300
Study Start Date: September 2005
Study Completion Date: July 2007
Arms Assigned Interventions
Active Comparator: group B
women in group B will receive 10 uts oxytocin IM
Drug: oxytocin
Active Comparator: group C
women in group C will receive oxytocin 5 uts IV
Drug: oxytocin
Active Comparator: group A
women in group A will receive oxytocin 5 uts IM
Drug: oxytocin

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00200252

Locations
Canada, Newfoundland and Labrador
Women's Health Centre, Eastern Health
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Sponsors and Collaborators
Memorial University of Newfoundland
Investigators
Principal Investigator: Colleen L Cook, MD Resident, Discipline Obstetrics and Gynecology, Memorial University of Newfoundland
Study Director: Joan Crane, MD Faculty, Discipline Obstetrics and Gynecolgy, Memorial University of Newfoundland
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00200252     History of Changes
Other Study ID Numbers: HIC05.79
Study First Received: September 12, 2005
Last Updated: November 8, 2012
Health Authority: Canada: Health Canada

Keywords provided by Memorial University of Newfoundland:
oxytocin
third stage
dose
route
blood loss

Additional relevant MeSH terms:
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014