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NCT07688512
Oxytocin Bolus Versus Infusion in High-Risk Patients Undergoing Elective Cesarean Section (INBOX-HR)
Conditions: Postpartum Hemorrhage, Uterine Atony, Uterine Atony With Hemorrhage, Elective Cesarean Section
Sex: Female
Ages: 18 Years – 45 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 180
Sponsor: Stony Brook University
Summary
The goal of this randomized, double-blind clinical trial is to learn if Oxytocin is most effective at achieving adequate uterine tone (important for preventing postpartum hemorrhage) when administered as a bolus or an infusion in patients at high-risk for postpartum hemorrhage in elective cesarean sections. The main questions that will be answered are:
1. Is Oxytocin bolus more effective than Oxytocin infusion at achieving adequate uterine tone at 2 minutes after the baby is born and every minute thereafter?
2. Does Oxytocin bolus cause less maternal side effects than Oxytocin infusion?
3. Does Oxytocin bolus result in less blood loss than Oxytocin infusion in high risk for postpartum hemorrhage patients undergoing elective cesarean sections?
3\. Are patients more satisfied with their cesarean section when they receive Oxytocin bolus or Oxytocin infusion?
Researchers will compare the 2 methods of Oxytocin administration, bolus versus infusion, to see which method is more effective or if they are equally effective.
Participants will:
1. Be randomized to receive either Oxytocin bolus or Oxytocin infusion during their cesarean section but after the baby is born.
2. Be asked a question about their experience 2 hours after the surgery.
3. Allow the research team to collect information about how they are doing from their hospital medical records.
Eligibility Criteria
Inclusion Criteria:
* Undergoing elective cesarean section under spinal anesthesia or combined spinal anesthesia (CSE)
* Patients must be able to provide written informed consent in either English or Spanish
* Parturient classified as high risk for postpartum hemorrhage as defined by the adapted California Maternal Quality Care Obstetric Hemorrhage Risk Screen
Exclusion Criteria:
* Parturient in labor or ruptured membranes
* Patient does not possess the physical and mental capacity to provide informed consent
* Urgent or emergent cesarean sections
* Patients with a known major coagulopathy
* Patients with significant thrombocytopenia limiting neuraxial anesthesia (\
Source: ClinicalTrials.gov (NCT07688512). StuddyBuddy aggregates publicly available trial information.