Actively Recruiting
Oxytocin Maintenance Infusion in Labouring Women Undergoing Cesarean Delivery: an Up-down Sequential Allocation Study
Led by Samuel Lunenfeld Research Institute, Mount Sinai Hospital · Updated on 2026-04-06
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the minimal effective dose of oxytocin infusion needed to maintain strong uterine contractions in women undergoing cesarean delivery after labor that was induced or augmented. Oxytocin is commonly used to help the uterus contract and reduce blood loss after delivery. This study uses a dose-finding method where each patient's oxytocin dose depends on the uterine response of the previous patient, aiming to identify the dose effective in 90% of patients (ED90). The study is a prospective, double-blinded clinical trial where patients, anesthesiologists, and obstetricians do not know the oxytocin dose given. Oxytocin will be infused at varying rates ranging from 4 IU/h to 36 IU/h, prepared in a 1-liter bag of Ringer's lactate infused at 125 ml/h. The infusion dose for each new patient is adjusted up or down based on the uterine tone observed in the prior patient. Participants will be monitored for uterine tone up to 2 hours after surgery in the post anesthetic care unit. Researchers will also assess blood loss, need for blood transfusions, bleeding episodes, and additional uterotonic medication use within 24 hours postpartum. Safety will be checked by measuring vital signs and heart rhythm, along with symptoms like nausea, vomiting, chest pain, shortness of breath, and headache during the first 2 hours after delivery. The study follows patients until discharge from the care unit.
CONDITIONS
Brief Title
Oxytocin Maintenance Infusion in Labouring Women Undergoing Cesarean Delivery: an Up-down Sequential Allocation Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- All patients with induced or augmented labour undergoing cesarean delivery under neuraxial anesthesia
- At least 3 hours of oxytocin exposure during labour
- Female patients aged 18 to 50 years
- Willingness to provide written informed consent
You will not qualify if you...
- Refusal to give written informed consent
- Allergy or hypersensitivity to oxytocin
- History of hypertension or severe cardiac disease
- Contraindications for neuraxial anesthesia
- Conversion to general anesthesia during surgery
- Presence of placenta previa or multiple gestation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 2 hours or until discharge from the post anesthetic care unit (PACU)
Participants receive an oxytocin maintenance infusion during and after cesarean delivery under neuraxial anesthesia to produce appropriate uterine contraction.
1 infusion during cesarean delivery and recovery
Trial Site Locations
Total: 1 location
1
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G1X5
Actively Recruiting
Research Team
M
Mrinalini Balki, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
10
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