Low-Dose Versus High-Dose Oxytocin Dosing for Induction and Augmentation of Labor
- Registration Number
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 170
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Low dose oxytocin 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. High dose oxytocin 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.
- Primary Outcome Measures
Name Time Method Time to delivery through study completion, expected to be 2 years Induction to delivery time interval
- Secondary Outcome Measures
Name Time Method Number of participants with uterine tachysystole through study completion, expected to be 2 years with and without fetal heart rate changes, need for cessation or decrease in oxytocin dosage
Rate of primary cesarean delivery through study completion, expected to be 2 years Rate of serious maternal morbidity and mortality through study completion, expected to be 2 years uterine rupture, admission to ICU, septicemia
Rate of neonatal infection through study completion, expected to be 2 years Rate of neonates with 5 min APGAR score <7 through study completion, expected to be 2 years Rate of umbilical artery acidemia through study completion, expected to be 2 years Rate of NICU admission through study completion, expected to be 2 years Mode of delivery through study completion, expected to be 2 years Vaginal or cesarean delivery
Number of participants with nausea/vomiting requiring antiemetics and diarrhea through study completion, expected to be 2 years Maternal side effects
Maximum dose of oxytocin infusion through study completion, expected to be 2 years Rate of postpartum hemorrhage through study completion, expected to be 2 years Rate of placental abruption through study completion, expected to be 2 years Rate of maternal infection (endometritis, chorioamnionitis) through study completion, expected to be 2 years Maternal side effects
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 through study completion, expected to be 2 years
Trial Locations
- Locations (1)
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States