NCT05236985

Oxytocin Bolus Versus Infusion in Elective Cesarean Section"

Randomized Double-Blinded Clinical Trial of Oxytocin Bolus Versus Infusion in Elective Cesarean Section

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Stony Brook University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

Bolus administration of oxytocin is superior to infusion in time to achieving adequate uterine tone.

Detailed description

Oxytocin is the most commonly used uterotonic agent worldwide to achieve adequate uterine tone and prevent postpartum hemorrhage. Over the past decade, the trend has been towards lowering the dose to reduce oxytocin-related adverse effects including nausea, hypotension, chest pain, EKG changes, and maternal death. However, the optimal strategy for oxytocin administration remains controversial. Prior literature found bolus doses less than 5 IU to be effective in achieving adequate uterine tone with a significant reduction in adverse side effects. There is limited high quality data comparing bolus versus infusion administration of oxytocin. The current standard of care at the institution is an infusion of oxytocin 18 IU/hour (0.3 IU/min) and has been proven to be effective in achieving adequate uterine tone. However, the time to uterine tone appears to be slightly longer (3-4 mins) with the infusion method. Given that the estimated uterine blood flow is between 500-700 mls/min, the uterus can lose a significant amount of blood per second if uterine tone is not achieved quickly. Thus, the purpose of this research study is to compare bolus and infusion administration of oxytocin on parturients undergoing elective cesarean section. The primary objective of this study is to test the hypothesis that administration by bolus (vs. standard of care infusion) results in more rapid achievement of adequate uterine tone. Secondary objectives include determining estimated blood loss, prevalence of hypotension, nausea, vomiting, and patient satisfaction.

Conditions

• Elective Cesarean Section

Interventions

Type	Name	Description
DRUG	Oxytocin bolus or oxytocin infusion	On the day of surgery, the patients will be randomized to either bolus or infusion administration of oxytocin. On the day of the procedure, periprocedural data and patient satisfaction (single question) will be recorded.

Timeline

• Start date: 2022-03-15
• Primary completion: 2024-12-15
• Completion: 2024-12-15
• First posted: 2022-02-11
• Last updated: 2024-03-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study