Low-Dose Versus High-Dose Oxytocin Dosing for Induction and Augmentation of Labor: A Randomized Control Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 170
- Locations
- 1
- Primary Endpoint
- Time to Delivery
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- 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
Arms & Interventions
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.
Intervention: Oxytocin (Low dose) (Drug)
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.
Intervention: Oxytocin (High dose) (Drug)
Outcomes
Primary Outcomes
Time to Delivery
Time Frame: Through delivery, on average 24 hours
Induction to delivery time interval
Secondary Outcomes
- 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))
- Rate of 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)(Through delivery, on average 24 hours)
- Rate of Serious Maternal Morbidity and 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)(Through delivery, on average 24 hours)