Low-Dose Versus High-Dose Oxytocin Dosing for Induction and Augmentation of Labor
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
- Labor Long
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
| Arm | Description | Assigned 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. |
|
|
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. |
|
Recruiting Locations
Galveston, Texas 77555
More Details
- Status
- Recruiting
- Sponsor
- The University of Texas Medical Branch, Galveston