NCT05782816

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2023

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 24, 2023

Completed
24 days until next milestone

Study Start

First participant enrolled

April 17, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2025

Completed
7 months until next milestone

Results Posted

Study results publicly available

January 9, 2026

Completed
Last Updated

January 9, 2026

Status Verified

December 1, 2025

Enrollment Period

1.7 years

First QC Date

February 21, 2023

Results QC Date

July 20, 2025

Last Update Submit

December 17, 2025

Conditions

Labor Long

Keywords

induction of laboraugmentation of laboroxytocinpitocinhigh dosemode of delivery

Outcome Measures

Primary Outcomes (1)

  • Time to Delivery

    Induction to delivery time interval

    Through delivery, on average 24 hours

Secondary Outcomes (12)

  • Mode of Delivery

    Through delivery, on average 24 hours

  • Rate of Primary Cesarean Delivery

    Through delivery, on average 24 hours

  • Maximum Dose of Oxytocin Infusion

    Through delivery, on average 24 hours

  • Rate of Uterine Tachysystole

    Through delivery, on average 24 hours

  • Number of Participants With Postpartum Hemorrhage

    From delivery through the postpartum period (average duration approximately 24 hours)

  • +7 more secondary outcomes

Study Arms (2)

Low dose oxytocin

ACTIVE COMPARATOR

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)

High dose oxytocin

ACTIVE COMPARATOR

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)

Interventions

Oxytocin (Low dose)DRUG

Low dose oxytocin

Also known as: Pitocin, Syntocinon
Low dose oxytocin
Oxytocin (High dose)DRUG

High dose oxytocin

Also known as: Pitocin, Syntocinon
High dose oxytocin

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Fetal growth restriction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

MeSH Terms

Interventions

Oxytocin

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Amanda Wang, MD
Organization
University of Texas Medical Branch
amanda.mei.wang@gmail.com
4097728666

Study Officials

  • Amanda Wang, MD

    University of Texas

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2023

First Posted

March 24, 2023

Study Start

April 17, 2023

Primary Completion

December 31, 2024

Study Completion

June 24, 2025

Last Updated

January 9, 2026

Results First Posted

January 9, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)