Status:
RECRUITING
Oxytocin and Fetal Heart Rate Changes
Lead Sponsor:
Unyime Ituk
Conditions:
Fetal Bradycardia Complicating Labor and Delivery
Fetal Bradycardia During Labor
Eligibility:
FEMALE
18-55 years
Phase:
PHASE4
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 neuraxia...
Detailed Description
Oxytocin is used in labor and delivery to increase the frequency of contractions and augment uterine contractile strength, thereby establishing a regular pattern of labor. However, the administration ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
730 Patients enrolled
Trial Details
Trial ID
NCT03232918
Start Date
February 20 2019
End Date
December 31 2025
Last Update
June 4 2025
Active Locations (2)
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1
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52245
2
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226