Oxytocin and Fetal Heart Rate Changes

  • STATUS
    Recruiting
  • End date
    Apr 30, 2024
  • participants needed
    730
  • sponsor
    Unyime Ituk
Updated on 24 May 2022
Accepts healthy volunteers

Summary

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.

Description

Oxytocin is used in labor and delivery to increase the frequency of contractions and augment uterine contractile strength, thereby establishing a regular pattern of labor. However, the administration of exogenous oxytocin in the presence of an uncoordinated labor pattern confers a risk for an increase in uterine contraction frequency, resulting in inadequate relaxation periods. This leads to an increase in the basal tone of the uterus, which may lead to a tetanic contraction with the risk of decreased uteroplacental blood flow and fetal hypoxemia. Previous studies investigating low- versus high-dose oxytocin for induction or augmentation of labor have had conflicting results on the effect on fetal heart rate abnormalities. One of the limitations of these studies is that the labor analgesia was not standardized. The combination of low-dose combined spinal epidural analgesia and the high/low dose oxytocin have not been evaluated. One of the proposed mechanisms for nonreassuring fetal heart a tracing after initiation of analgesia is that the pain relief from neuraxial analgesia causes a decrease in catecholamine release by the sympathetic nervous system. The subsequent decrease in the circulating epinephrine concentration contributes to an increase in uterine tone, as epinephrine is a potent tocolytic agent. The increased tone, in turn, leads to a decrease in placental blood flow, and eventually fetal bradycardia. The primary outcome of this study is the incidence of non-reassuring fetal heart rate tracings within the first 60 minutes after the placement of combined spinal epidural analgesia

Details
Condition Fetal Bradycardia Complicating Labor and Delivery, Fetal Bradycardia During Labor, Fetal Heart Rate or Rhythm Abnormality Affecting Fetus
Treatment Half dose Oxytocin
Clinical Study IdentifierNCT03232918
SponsorUnyime Ituk
Last Modified on24 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

Use of chronic analgesic medications
Prior administration of systemic opioid labor analgesia
Non-vertex presentation
Contraindication to neuraxial analgesia
Category 3 fetal heart rate tracing prior to the initiation of combined spinal epidural analgesia
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