Pharmacokinetic and Pharmacodynamic Investigations of Fetal Anesthesia During Maternal Fetal Surgery

Conditions

• Fetal Anesthesia

Eligibility Criteria

Sex

FEMALE

Age

13 Years - N/A

Healthy Volunteers

Accepted

Study Details

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 Dates

Start date

May 1, 2026

Status verified

Apr 2026

Primary completion

May 1, 2026

Completion

May 1, 2027

Study Design

Enrollment

10 participants (estimated)

Arms

• Arm: Pregnant women undergoing maternal-fetal surgery
  Pregnant women undergoing maternal-fetal surgery requiring fetal anesthesia. This study is purely observational.

Primary Outcome Measure

Maximum plasma concentration (Cmax) of fetal anesthesia [ Time Frame: 2 years ]

Central Contacts

• Julia Atayde, BS
  617-355-2967
  [email protected]
• Rachel Bernier, BS, MPH
  857-218-5348
  [email protected]

Locations (1)

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