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

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ClinicalTrials.gov Identifier: NCT00200252
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : November 9, 2012
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Third Stage of Labour Drug: oxytocin Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intramuscular Versus Intravascular Oxytocin for the Third Stage of Labour
Study Start Date : September 2005
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. change in hematocrit

Secondary Outcome Measures :
  1. estimated blood loss
  2. postpartum hemorrhage (estimated blood loss > 500cc)
  3. severe postpartum hemorrhage (estimated blood loss > 1000cc)
  4. incidence of hypotension
  5. length of third stage of labour
  6. need for blood transfusion
  7. incidence of retained placenta
  8. need for dilatation and curettage
  9. need for hysterectomy
  10. need for additional oxytocics after delivery
  11. postpartum antibiotic use
  12. maternal satisfaction
  13. bleeding needing readmission


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00200252     History of Changes
Other Study ID Numbers: HIC05.79
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: November 9, 2012
Last Verified: November 2012

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