Oxytocin Bolus Versus Infusion in High-Risk Patients Undergoing Elective Cesarean Section (INBOX-HR) (NCT07688512) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Oxytocin Bolus Versus Infusion in High-Risk Patients Undergoing Elective Cesarean Section (INBOX-HR)
180 participantsStarted 2026-08
Plain-language 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.
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 (\<70k)
* Patients on therapeutic anticoagulation at time of procedure
* Patients on the placenta accreta spectrum
* Patients with severe cardiac disease contraindicating oxytocin
* Patients with an allergy to oxytocin
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time to uterine tone
Timeframe: 2 minutes after umbilical cord clamp until 10 minutes.