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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 50 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
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 oxytocin
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 oxytocin

Recruiting Locations

University of Texas Medical Branch
Galveston, Texas 77555
Contact:
Amanda Wang, MD
409-772-2891
ammwang@utmb.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Medical Branch, Galveston

Study Contact

Amanda Wang, MD
409-772-2891
ammwang@utmb.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.