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NOT YET RECRUITING
NCT07688512
PHASE4

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

Sponsor: Stony Brook University

View on ClinicalTrials.gov

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.

Official title: Randomized Double-Blinded Clinical Trial of Oxytocin Bolus Versus Infusion in High-Risk Patients Undergoing Elective Cesarean Section

Key Details

Gender

FEMALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

180

Start Date

2026-08

Completion Date

2029-02

Last Updated

2026-08-03

Healthy Volunteers

No

Interventions

DRUG

Oxytocin Bolus or Oxytocin Infusion

On 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.