About this trial
The reported risk of nonreassuring fetal heart trace following neuraxial analgesia is 3-23%. This variability may be due to fluid and oxytocin management prior to and during the initiation of neuraxial analgesia. The study hypothesis is that decreasing the oxytocin infusion rate by 50 % prior to initiation of combined spinal epidural analgesia will cause a reduction in the incidence of adverse fetal heart rate changes.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy nulliparous or multiparous women at term (37 > weeks' gestation)
Singleton pregnancy
Request for neuraxial analgesia
Oxytocin used for induction of labor or augmentation of labor per institutional protocols
Disqualifiers
Use of chronic analgesic medications
Prior administration of systemic opioid labor analgesia
Non-vertex presentation
Contraindication to neuraxial analgesia
Trial design
Parallel
Treatments tested in this trial
Half dose Oxytocin
DrugPatients randomized to the half dose oxytocin group will have the oxytocin infusion reduced to 50 % prior to placement of combined spinal epidural for labor analgesia
Treatment groups
Trial outcomes
Primary outcomes
Incidence of non-reassuring fetal heart rate tracings
Fetal heart rate tracings will be examined for 30 minutes before and 60 minutes after the initiation of combined spinal epidural analgesia
Secondary outcomes
Effect of oxytocin dose on duration of 1st and 2nd stage of labor
The effect of the intervention on the duration of labor
Mode of delivery
The effect of the intervention on the rate of spontaneous vaginal delivery, instrumental vaginal delivery and cesarean delivery
Sponsors and contacts
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Unyime Ituk
Lead sponsor
University of Iowa
Sponsor institution