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

NCT07688512 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-08-03

No results posted yet for this study

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.

Conditions

  • Postpartum Hemorrhage
  • Uterine Atony
  • Uterine Atony With Hemorrhage
  • Elective Cesarean Section

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.

Sponsors & Collaborators

Principal Investigators

  • Tiffany E Angelo, DO, FASA · Stony Brook University Hospital Department of Anesthesiology

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2028-08-31
Completion
2029-02-28
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07688512 on ClinicalTrials.gov