Oxytocin and Fetal Heart Rate Changes

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-55
SponsorUnyime Ituk

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Half dose Oxytocin

    Drug

    Patients 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

730 Participants
are divided into 2 treatment groups
Group A: Standard Dose OxytocinNo intervention 0 interventions
Group B: Half Dose OxytocinExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
1.5 hours

Secondary outcomes

1

Effect of oxytocin dose on duration of 1st and 2nd stage of labor

The effect of the intervention on the duration of labor

Time frame
24 hours
2

Mode of delivery

The effect of the intervention on the rate of spontaneous vaginal delivery, instrumental vaginal delivery and cesarean delivery

Time frame
24 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Unyime Ituk

Lead sponsor

University of Iowa

Sponsor institution