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

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.

Study Overview

• Status: Completed
• Conditions: Labor Long
• Intervention / Treatment: Drug: Oxytocin (Low dose); Drug: Oxytocin (High dose)

• Study Type: Interventional
• Enrollment (Actual): 170
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Galveston, Texas, United States, 77555
      • University of Texas Medical Branch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: Oxytocin (Low dose); Low dose oxytocin; Other Names: Pitocin; Syntocinon
Active Comparator: 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.	Drug: Oxytocin (High dose); High dose oxytocin; Other Names: Pitocin; Syntocinon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Delivery	Induction to delivery time interval	Through delivery, on average 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mode of Delivery	Vaginal or cesarean delivery	Through delivery, on average 24 hours
Rate of Primary Cesarean Delivery	Number of participants with primary cesarean delivery.	Through delivery, on average 24 hours
Maximum Dose of Oxytocin Infusion	The highest oxytocin infusion rate administered to a participant during the study period.	Through delivery, on average 24 hours
Rate of Uterine Tachysystole	The number of participants with and without fetal heart rate changes and the need for cessation or decrease in oxytocin dosage.	Through delivery, on average 24 hours
Number of Participants With Postpartum Hemorrhage		From delivery through the postpartum period (average duration approximately 24 hours)
Rate of Placental Abruption	The number of participants with placental abruption.	Through delivery, on average 24 hours
Number of Participants With Nausea/Vomiting Requiring Antiemetics and Diarrhea		From delivery (average duration approximately 24 hours)
Rate of Maternal Infection (Endometritis, Chorioamnionitis)	The number of participants with maternal maternal infections (endometritis, choriomnionitis)	Through delivery, on average 24 hours
Rate of Serious Maternal Morbidity and Mortality	The number of participants with uterine rupture, admission to ICU, and septicemia or mortality.	Through delivery, on average 24 hours
Number of Neonates With One or More of: Perinatal Death, Severe Respiratory Distress Requiring Ventilation, Neonatal Encephalopathy, Neonatal Seizure, Neonatal Sepsis, 5-minute APGAR Score <7, Umbilical Artery Acidemia, Neonatal ICU Admission		From birth through 24 hours
Number of Participants With Neonatal Sepsis (Confirmed With Cultures)		From birth through 24 hours
Rate of Umbilical Artery Acidemia (Base Excess <12)	Number of participants with umbilical artery acidemia (base excess <12).	Through delivery, on average 24 hours

Collaborators and Investigators

• Sponsor: The University of Texas Medical Branch, Galveston
• Investigators: Principal Investigator: Amanda Wang, MD, University of Texas

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2023
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): June 24, 2025

Study Registration Dates

• First Submitted: February 21, 2023
• First Submitted That Met QC Criteria: March 20, 2023
• First Posted (Actual): March 24, 2023

Study Record Updates

• Last Update Posted (Actual): January 9, 2026
• Last Update Submitted That Met QC Criteria: December 17, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: oxytocin; high dose; induction of labor; mode of delivery; pitocin; augmentation of labor
• Additional Relevant MeSH Terms: Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Pituitary Hormones, Posterior; Pituitary Hormones; Oxytocin
• Other Study ID Numbers: 22-0240

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No