What this study is
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's being tested
- Half dose Oxytocin
Intervention · DRUG
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
Study details
- 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
- Sponsor
- Unyime Ituk
- Conditions
- Fetal Bradycardia Complicating Labor and Delivery · Fetal Bradycardia During Labor · Fetal Heart Rate or Rhythm Abnormality Affecting Fetus
- Enrolling
- 730 people
- Starts
- 2019-02-20
- Est. completion
- 2025-12-31
- Design
- Triple-blind, randomized, parallel groups, Phase 4
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 55 YearsSex FEMALEHealthy volunteers AcceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openUniversity of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
- Unyime Ituk, MD · Contact319-356-2633unyime-ituk@uiowa.edu
- Zita A Sibenaller, PhD · Contact319-356-8878zita-sibenaller@uiowa.edu
RecruitingMedical College of Wisconsin
Milwaukee, Wisconsin, United States
- Meredith Albrecht, MD · Contactmaaalbrecht@mcw.edu
Not yet recruiting
Study team
Sponsor
Unyime Ituk
Study ID 201609722
Study director
Unyime Ituk
University of Iowa
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.