RecruitingPhase 4NCT03232918

Oxytocin and Fetal Heart Rate Changes

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


Sponsor

Unyime Ituk

Enrollment

730 participants

Start Date

Feb 20, 2019

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 55 Years

Inclusion Criteria4

  • 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 Criteria5

  • 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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Interventions

DRUGHalf dose Oxytocin

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


Locations(2)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

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NCT03232918


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