Complications; Cesarean Section Clinical Trial
Official title:
Intravenous Oxytocin Use to Decrease Blood Loss During Cesarean Section. What is the Optimal Dose: A Randomized Blinded Trial
The goal of this study is to determine the best dose of a drug called oxytocin, that is usually used to stop bleeding during a delivery, when used during a cesarean delivery. It will be administered during cesarean section in order to decrease the amount blood loss. The investigators are proposing to have 3 groups of subjects each given a different safe dose of oxytocin and then to assess the effectiveness of each regimens on the amount blood lost during cesarean sections.This will let use know which is the best lowest dose needed.
Status | Completed |
Enrollment | 200 |
Est. completion date | February 2013 |
Est. primary completion date | February 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 15 Years to 45 Years |
Eligibility |
Inclusion Criteria: - Study subjects will be women delivering via an elective cesarean section at term - All study subjects will have singleton gestation with no obstetric or medical complication. Exclusion Criteria: - Laboring women - Multifetal gestation - Prolonged oxytocin use (>12 hours) - Hypertensive disorders - Chorioamnionitis - Suspected macrosomia - Polyhydramnios - History of postpartum Hemorrhage - Clotting disorder - Intake of magnesium sulfate - Uterine fibroids - Placenta previa - Placental abruption - Anticoagulation |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Lebanon | American University of Beirut Medical Center | Beirut |
Lead Sponsor | Collaborator |
---|---|
American University of Beirut Medical Center |
Lebanon,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The change in hemoglobin as a measure of blood loss. The change in hemoglobin is defined as the difference between the predelivery hemoglobin value and the postpartum value | 1 year | No | |
Secondary | The need for blood transfusion and the use of additional uterotonic agents, pad weight, pad count, estimated blood loss. | 1 year | No |
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