Low-Dose Versus High-Dose Oxytocin Dosing for Induction and Augmentation of Labor
NCT ID: NCT05782816
Last Updated: 2026-01-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
170 participants
INTERVENTIONAL
2023-04-17
2025-06-24
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Low dose oxytocin
The low dose oxytocin group will receive a controlled infusion pump at a proximal port on the peripheral IV line. The infusion will start at 2 milli-units/min and will be increased by 2 milli-units/min every 20 minutes. Maximum rate of infusion is 40 milli-units/min. Oxytocin infusion rate is adjusted to maintain adequate uterine contractions.
Oxytocin (Low dose)
Low dose oxytocin
High dose oxytocin
The high dose oxytocin group will receive a controlled infusion pump at a proximal port on the peripheral IV line. The infusion will 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. Oxytocin infusion rate is adjusted to maintain adequate uterine contractions.
Oxytocin (High dose)
High dose oxytocin
Interventions
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Oxytocin (Low dose)
Low dose oxytocin
Oxytocin (High dose)
High dose oxytocin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Singleton gestation
* Nulliparous
* Vertex presentation
* Gestational age greater than or equal to 37 weeks
* No prior uterine surgery
* Presents for elective or medically indicated induction of labor
* Need for augmentation of labor with oxytocin
Exclusion Criteria
* Patient unable or unwilling to provide verbal consent
* Contraindications to vaginal delivery
* Fetal demise or life-limiting anomaly
* Allergy to oxytocin
* Non-reassuring fetal heart tracing prior to inclusion
* Maternal pulmonary edema prior to inclusion
* Fetal growth restriction
18 Years
50 Years
FEMALE
No
Sponsors
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The University of Texas Medical Branch, Galveston
OTHER
Responsible Party
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Principal Investigators
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Amanda Wang, MD
Role: PRINCIPAL_INVESTIGATOR
University of Texas
Locations
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University of Texas Medical Branch
Galveston, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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22-0240
Identifier Type: -
Identifier Source: org_study_id
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