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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00200252 |
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Date of registration:
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12/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Oxytocin Administration in the Third Stage of Labour - A Study of Appropriate Route and Dose
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Scientific title:
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Intramuscular Versus Intravascular Oxytocin for the Third Stage of Labour |
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Date of first enrolment:
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September 2005 |
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Target sample size:
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300 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00200252 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Canada
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Contacts
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Name:
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Joan Crane, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Faculty, Discipline Obstetrics and Gynecolgy, Memorial University of Newfoundland |
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Name:
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Colleen L Cook, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Resident, Discipline Obstetrics and Gynecology, Memorial University of Newfoundland |
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Key inclusion & exclusion criteria
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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
Age minimum:
19 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Third Stage of Labour
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Intervention(s)
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Drug: oxytocin
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Primary Outcome(s)
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change in hematocrit
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Secondary Outcome(s)
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incidence of retained placenta
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bleeding needing readmission
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severe postpartum hemorrhage (estimated blood loss > 1000cc)
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postpartum antibiotic use
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maternal satisfaction
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need for dilatation and curettage
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incidence of hypotension
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length of third stage of labour
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postpartum hemorrhage (estimated blood loss > 500cc)
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need for additional oxytocics after delivery
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need for hysterectomy
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estimated blood loss
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need for blood transfusion
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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