Oxytocin and Fetal Heart Rate Changes

Last updated: May 13, 2024
Sponsor: Unyime Ituk
Overall Status: Active - Recruiting

Phase

4

Condition

Heart Disease

Low Blood Pressure (Hypotension)

Dysrhythmia

Treatment

Half dose Oxytocin

Clinical Study ID

NCT03232918
201609722
  • Ages 18-55
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 institutionalprotocols

Exclusion

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 spinalepidural analgesia

Study Design

Total Participants: 730
Treatment Group(s): 1
Primary Treatment: Half dose Oxytocin
Phase: 4
Study Start date:
February 20, 2019
Estimated Completion Date:
December 31, 2025

Study 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

Connect with a study center

  • University of Montreal

    Montreal, Quebec
    Canada

    Site Not Available

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa 52245
    United States

    Active - Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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