Oxytocin and Fetal Heart Rate Changes
Unyime Ituk · NCT03232918
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–55 · Women only
- Healthy volunteers
- Accepted
- Study type
- Interventional · Phase 4
- Target enrollment
- 730
- US sites recruiting
- 1
- Study start
- February 20, 2019
- Record last updated
- June 4, 2025
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: Half dose Oxytocin
Conditions: Fetal Bradycardia Complicating Labor and Delivery; Fetal Bradycardia During Labor; Fetal Heart Rate or Rhythm Abnormality Affecting Fetus
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
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
Recruiting US locations
University of Iowa Hospitals and Clinics
Iowa City, IA 52245
Site contact: Unyime Ituk, MD · 319-356-2633 · unyime-ituk@uiowa.edu
Study contacts (from the official record)
- Unyime Ituk · 319-356-2633 · unyime-ituk@uiowa.edu
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