Intravenous Oxytocin Use to Decrease Blood Loss During Cesarean Section. What is the Optimal Dose: A Randomized Blinded Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- 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
Study Overview
Brief Summary
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.
Detailed Description
This trial will be a randomized, blinded controlled trial that will be conducted at the American University of Beirut Medical Center Labor and Delivery Unit.
Identification of candidates:
- All women admitted to the Delivery Suite for elective cesarean delivery or needing cesarean delivery for obstetric reasons will be invited to participate in the study.
- Women will then be approached by the research assistants and/or investigators who will explain the objectives of the study and will ask eligible women to participate in the trial and sign a consent form.
Study subjects will be randomized using a computer-generated random number sequence stratified by elective or emergency cesarean section. At surgery, a sealed opaque envelope containing the randomization number and data sheet will be opened for each consenting patient.
Interventions:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 15 Years to 45 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
oxytocin
group 1 will receive oxytocin solutions with 20U/500ml during cesarean section
Intervention: Oxytocin (Drug)
oxytocin2
group 2 will receive oxytocin solutions with 30U/500ml during cesarean section
Intervention: Oxytocin (Drug)
oxytocin3
group 3 will receive oxytocin solutions with 40U/500ml during cesarean section
Intervention: Oxytocin (Drug)
Outcomes
Primary Outcomes
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
Time Frame: 1 year
Secondary Outcomes
- The need for blood transfusion and the use of additional uterotonic agents, pad weight, pad count, estimated blood loss.(1 year)
Investigators
Dr. Labib Ghulmiyeh
Assistant Professor
American University of Beirut Medical Center