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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Oxytocin Bolus or Oxytocin Infusion
DrugOn the day of surgery, patients will be randomized to receive either bolus or infusion administration of Oxytocin. On the day of the procedure, periprocedural data and patient satisfaction (single question) will be recorded.
Treatment groups
180 Participants
are divided into 2 treatment groupsGroup A: Oxytocin BolusActive comparator 1 intervention
Group B: Oxytocin InfusionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Time to uterine tone
Uterine tone will be assessed at 2 mins and then every minute thereafter until adequate uterine tone is attained but no more than 10 minutes maximum, by a blinded obstetrician. Uterine tone will be deemed adequate or inadequate by the blinded obstetrician. The time for the primary endpoint analysis is adequacy of uterine tone at 2 minutes after the baby is born/umbilical cord clamped.
Time frame
2 minutes after umbilical cord clamp until 10 minutes.Secondary outcomes
1
Estimated intraoperative blood loss
Time frame
From the start to end of surgery2
Changes in heart rate (beats per minute)
Time frame
During uterine cord clamp and every 2 minutes thereafter until 10 minutes3
Changes in blood pressure (mmHg)
Time frame
During uterine cord clamp and every 2 minutes thereafter until 10 minutes.4
Total dose of phenylephrine administered intraoperatively
Time frame
From the start to end of surgeryLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: