Pharmacokinetic and Pharmacodynamic Investigations of Fetal Anesthesia During Maternal Fetal Surgery
Starting soon
Conditions studied: Fetal Anesthesia
In brief
This study examines how three medications commonly used during fetal surgery, fentanyl, rocuronium, and atropine, behave in the fetus. The primary goal is to understand their pharmacokinetics (how the drugs are absorbed, distributed, and cleared), pharmacodynamics (how they affect fetal physiology), and how they transfer between mother and fetus through the placenta. The secondary goal is to measure drug levels in discarded fetal blood samples collected during clinically indicated procedures and relate those levels to fetal heart rate, heart rate variability, movement, gestational age, and fetal size. An optional maternal blood draw component will allow comparison of maternal and fetal drug concentrations to better understand placental transfer. The study does not change clinical care or require extra fetal procedures, and findings may help create safer, evidence-based fetal anesthesia dosing strategies tailored to gestational age.
Key facts
- Study ID
- NCT07571811
- Run by
- Boston Children's Hospital
- People needed
- 10
- Starts
- 2026-05-01
- Expected to finish
- 2027-05-01
- Last updated by the study team
- 2026-05-06
Who can join
Age: 13 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Pregnant and undergoing maternal-fetal surgery requiring clinically indicated fetal anesthesia and planned fetal blood sampling as part of usual fetal care
- Fetus is with or without congenital heart disease
You may not qualify if…
- Patient or fetus have any known liver or kidney disease
- Patient or fetus has any known allergy to fentanyl, rocuronium, or atropine
- Patient has taken inhibitors, inducers or substrates of CYP3A4 other than midazolam (including erythromycin, ranitidine, verapamil, antihistamines, and dextromethorphan) within 24 hours of surgery.
Where it is running
- Boston Children's Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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