Low-Dose Versus High-Dose Oxytocin Dosing for Induction and Augmentation of Labor
NCT05782816 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 170
Last updated 2026-01-09
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
- DRUG
-
Oxytocin (Low dose)
Low dose oxytocin
- DRUG
-
Oxytocin (High dose)
High dose oxytocin
Sponsors & Collaborators
-
The University of Texas Medical Branch, Galveston
lead OTHER
Principal Investigators
-
Amanda Wang, MD · University of Texas
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-04-17
- Primary Completion
- 2024-12-31
- Completion
- 2025-06-24
- FDA Drug
- Yes
Countries
- United States
Study Locations
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