Home › NCT03232918
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
Who can join
Ages 18 to 55 · Women · Healthy volunteers welcome
Full eligibility 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
About the study
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.
What is being tested
- Half dose Oxytocin (drug)
Sponsor: Unyime Ituk · Participants: 730 · Started: Feb 20, 2019
Contact the study team
- Unyime Ituk · Phone: 319-356-2633
Official record on ClinicalTrials.gov — NCT03232918
Locations in the U.S.
| Iowa | University of Iowa Hospitals and Clinics, Iowa City |
| Wisconsin | Medical College of Wisconsin, Milwaukee (Not yet recruiting) |
From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.