NCT05782816

Low-Dose Versus High-Dose Oxytocin Dosing for Induction and Augmentation of Labor

Low-Dose Versus High-Dose Oxytocin Dosing for Induction and Augmentation of Labor: A Randomized Control Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 170 (actual)
• Sponsor: The University of Texas Medical Branch, Galveston · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to compare oxytocin infusion rates for induction and augmentation of labor in nulliparous women. The main question\[s\] it aims to answer are: * Does a high dose oxytocin infusion protocol affect length of induction to delivery interval? * Does a high dose oxytocin infusion protocol affect mode of delivery? * Does a high dose oxytocin infusion protocol affect maternal and neonatal outcomes? Participants will be randomized to either low- or high-dose oxytocin groups: * The low dose group will receive an infusion to start at 2 milli-units/min and will be increased by 2 milli-units/min every 20 minutes. The maximum rate of infusion is 40 milli-units/min. * The high dose group will receive an infusion to start at 6 milli-units/min and will be increased by 6 milli-units/min every 20 minutes. Maximum rate of infusion is 40 milli-units/min.

Conditions

• Labor Long

Interventions

Type	Name	Description
DRUG	Oxytocin (Low dose)	Low dose oxytocin
DRUG	Oxytocin (High dose)	High dose oxytocin

Timeline

• Start date: 2023-04-17
• Primary completion: 2024-12-31
• Completion: 2025-06-24
• First posted: 2023-03-24
• Last updated: 2026-01-09
• Results posted: 2026-01-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study