Recruiting

Oxytocin & Fetal Heart Rate

Sponsor:

Unyime Ituk

Code:

NCT03232918

Conditions

Fetal Bradycardia Complicating Labor and Delivery

Fetal Bradycardia During Labor

Fetal Heart Rate or Rhythm Abnormality Affecting Fetus

Eligibility Criteria

Sex: Female

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

Half dose Oxytocin

Study Details

Brief 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.

Conditions

Fetal Bradycardia Complicating Labor and Delivery

Fetal Bradycardia During Labor

Fetal Heart Rate or Rhythm Abnormality Affecting Fetus

Study ID

NCT03232918

Start date

Feb 20, 2019

Status verified date

May, 2025

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 55

Healthy Volunteers: Accepted

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

Study Design

Enrollment

730 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Standard Dose Oxytocin

Patients randomized to the standard dose oxytocin will have their oxytocin infusion maintained at the standard of care protocol prior to placement of a combined spinal epidural for labor analgesia

experimental: Half Dose Oxytocin

Patients randomized to the half dose oxytocin will have their oxytocin infusion reduced by 50 % prior to placement of a combined spinal epidural for labor analgesia.

Interventions

Half 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

Primary outcome measure

  • Incidence of non-reassuring fetal heart rate tracings [ Time Frame: 1.5 hours ]

Central Contacts and Locations

Central contacts

Unyime Ituk

319-356-2633unyime-ituk@uiowa.edu

Locations

University of Iowa Hospitals and Clinics

Recruiting

Iowa City, Iowa, United States, 52245

Contacts

Unyime Ituk, MD

319-356-2633unyime-ituk@uiowa.edu

Zita A Sibenaller, PhD

319-356-8878zita-sibenaller@uiowa.edu

More Information

Sponsor

Unyime Ituk

Last update posted

Jun 4, 2025

Last verified

May, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Unyime Ituk on 2025-06-04.