Reducing oxytocin during labor to improve fetal heart rate outcomes
Official title: 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
Run by University of Iowa · NCT03232918 · Data updated 2026-11-12
This study tests if lowering the amount of oxytocin given during labor can help improve fetal heart rate patterns in healthy women having their first baby.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 55 Years |
| Sex | Women only |
| Enrollment | 730 (estimated) |
| Sponsor | University of Iowa Academic / other |
| Locations | 2 sites (Iowa City, Iowa and 1 other locations) |
| Status | Recruiting |
| Started | February 20, 2019 |
| Main results expected | December 31, 2025 |
| Study ends | December 31, 2025 |
| Registry record updated | June 4, 2025 |
| Trial ID | NCT03232918 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are healthy women at term with singleton pregnancies who are requesting neuraxial analgesia for labor induction or augmentation.
✕Probably not a fit
Patients with contraindications to neuraxial analgesia or those presenting with non-vertex fetal positions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the impact of reducing the oxytocin infusion rate by 50% prior to the initiation of combined spinal epidural analgesia on fetal heart rate changes during labor. It aims to determine if this adjustment can decrease the incidence of nonreassuring fetal heart rate patterns, which can occur due to increased uterine tone and decreased placental blood flow. The study focuses on healthy women at term with singleton pregnancies who request neuraxial analgesia and are undergoing labor induction or augmentation. By standardizing labor analgesia and oxytocin administration, the study seeks to clarify the relationship between oxytocin dosage and fetal heart rate abnormalities.
Why it matters
Potential benefit: If successful, this approach could lead to improved fetal heart rate outcomes and reduce the risk of fetal distress during labor.
How similar studies have gone: Previous studies on oxytocin dosing have shown mixed results, indicating that this approach is novel and may provide new insights into labor management.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States Recruiting -
Medical College of Wisconsin
Milwaukee, Wisconsin, United States Not yet recruiting
Study contacts
- Study coordinator: Unyime Ituk
- Email: unyime-ituk@uiowa.edu
- Phone: 319-356-2633
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.