Oxytocin Administration in the Third Stage of Labour - A Study of Appropriate Route and Dose
November 8, 2012 updated by: Memorial University of Newfoundland
Intramuscular Versus Intravascular Oxytocin for the Third Stage of Labour
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 Overview
Study Type
Interventional
Enrollment (Actual)
300
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Canada, A1B 3V6
- Women's Health Centre, Eastern Health
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: group B
women in group B will receive 10 uts oxytocin IM
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Active Comparator: group C
women in group C will receive oxytocin 5 uts IV
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|
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Active Comparator: group A
women in group A will receive oxytocin 5 uts IM
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
|
change in hematocrit
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Secondary Outcome Measures
Outcome Measure |
|---|
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estimated blood loss
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postpartum hemorrhage (estimated blood loss > 500cc)
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severe postpartum hemorrhage (estimated blood loss > 1000cc)
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incidence of hypotension
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length of third stage of labour
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need for blood transfusion
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incidence of retained placenta
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need for dilatation and curettage
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need for hysterectomy
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need for additional oxytocics after delivery
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postpartum antibiotic use
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maternal satisfaction
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bleeding needing readmission
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2005
Study Completion (Actual)
July 1, 2007
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 20, 2005
Study Record Updates
Last Update Posted (Estimate)
November 9, 2012
Last Update Submitted That Met QC Criteria
November 8, 2012
Last Verified
November 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HIC05.79
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.