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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
170
Low dose oxytocin
High dose oxytocin
University of Texas Medical Branch
Galveston, Texas, United States
Time to Delivery
Induction to delivery time interval
Time frame: Through delivery, on average 24 hours
Mode of Delivery
Vaginal or cesarean delivery
Time frame: Through delivery, on average 24 hours
Rate of Primary Cesarean Delivery
Number of participants with primary cesarean delivery.
Time frame: Through delivery, on average 24 hours
Maximum Dose of Oxytocin Infusion
The highest oxytocin infusion rate administered to a participant during the study period.
Time frame: Through delivery, on average 24 hours
Rate of Uterine Tachysystole
The number of participants with and without fetal heart rate changes and the need for cessation or decrease in oxytocin dosage.
Time frame: Through delivery, on average 24 hours
Number of Participants With Postpartum Hemorrhage
Time frame: From delivery through the postpartum period (average duration approximately 24 hours)
Rate of Placental Abruption
The number of participants with placental abruption.
Time frame: Through delivery, on average 24 hours
Number of Participants With Nausea/Vomiting Requiring Antiemetics and Diarrhea
Time frame: From delivery (average duration approximately 24 hours)
Rate of Maternal Infection (Endometritis, Chorioamnionitis)
The number of participants with maternal maternal infections (endometritis, choriomnionitis)
Time frame: Through delivery, on average 24 hours
Rate of Serious Maternal Morbidity and Mortality
The number of participants with uterine rupture, admission to ICU, and septicemia or mortality.
Time frame: 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
Time frame: From birth through 24 hours
Number of Participants With Neonatal Sepsis (Confirmed With Cultures)
Time frame: From birth through 24 hours
Rate of Umbilical Artery Acidemia (Base Excess <12)
Number of participants with umbilical artery acidemia (base excess \<12).
Time frame: Through delivery, on average 24 hours
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