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

The University of Texas System (UT)

Status and phase: Completed; Phase 4

Conditions: Labor Long

Treatments: Drug: Oxytocin (Low dose); Drug: Oxytocin (High dose)

Study type: Interventional

Funder types: Other

Identifiers

NCT05782816

22-0240

Details and patient eligibility

About

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.

Enrollment: 170 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women aged 18-50 years old
• 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

• Previous cervical ripening using non-mechanical methods
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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170 participants in 2 patient groups

Low dose oxytocin

Active Comparator group

Description:

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.

Treatment:

Drug: Oxytocin (Low dose)

High dose oxytocin

Active Comparator group

Description:

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.

Treatment:

Drug: Oxytocin (High dose)