Oxytocin Administration in the Third Stage of Labour - A Study of Appropriate Route and Dose
This study has been completed.
Sponsor:
Memorial University of Newfoundland
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
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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
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 May 22, 2013