Comparison of Intrathecal Versus Epidural Fentanyl on Fetal Bradycardia in Labor Combined Spinal Epidural Analgesia

• Status: Recruiting
• Trial end date: 2023-10-31
• Target enrollment: 0
• Participant gender: Female

Summary

There have been studies reporting that combined spinal-epidural (CSE) with fentanyl and bupivacaine produce fetal bradycardia, (M.Kuczkowski, 2004) (Abrão K, 2009 ). It is unknown whether any differences in risk exist between fentanyl and bupivacaine when used as a part of the CSE procedure. Some authors have reported cases of parturients who developed uterine hyperactivity and fetal bradycardia after subarachnoid administration of fentanyl during labor. (D'Angelo & Eisenach, 1997) (Friedlander JD, 1997). It has been suggested that uterine hypertonus, leading to non-reassuring fetal heart rate tracings, might be an etiologic factor in these situations. (Landau, 2002).

We propose this study to test the hypothesis that administration of epidural fentanyl is associated with a lower incidence of fetal bradycardia compared to intrathecal fentanyl.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Augusta University
• Treatments: Bupivacaine; Fentanyl

Criteria

Inclusion Criteria:

• Older than 18 years

• Term pregnancy (> 37 weeks)

• Absence of obstetric morbidities

• Active labor

• Request of neuraxial analgesia per patient and/or obstetrician

• Combined spinal-epidural technique

Exclusion Criteria:

• Abnormal fetal heart rate tracing.

• Uterine tachysystole before neuraxial analgesia.

• Baseline blood pressure <90/60 mmHg.

• Allergies to local anesthetics or fentanyl.

• Maternal fever.

• Pruritus before performance of neuraxial analgesia.

• Contraindications for neuraxial technique.

• Unwillingness to participate.