Oxytocin and Fetal Heart Rate Changes



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 55
Updated:2/24/2019
Start Date:February 20, 2019
End Date:April 30, 2021
Contact:Unyime Ituk
Email:unyime-ituk@uiowa.edu
Phone:319-356-2633

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A Randomized Controlled Trial Evaluating the Effect of the Oxytocin Infusion Rate on Fetal Heart Rate Changes and Maternal-Fetal Outcomes During the Initiation of Combined Spinal-Epidural Labor Analgesia

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.

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

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
We found this trial at
2
sites
200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
Phone: 319-356-2633
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Iowa City, IA
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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Milwaukee, WI
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