Oxytocin Bolus Versus Infusion in High-Risk Patients Undergoing Elective Cesarean Section (INBOX-HR)

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorStony Brook University

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Oxytocin Bolus or Oxytocin Infusion

Treatment groups

180 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators