Pharmacokinetic and Pharmacodynamic Investigations of Fetal Anesthesia During Maternal Fetal Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Fetal Anesthesia. Basic parameters: from 13 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Maximum plasma concentration (Cmax) of fetal anesthesia [Time frame: 2 years]
- Area under the plasma concentration versus time curve (AUC) of fetal anesthesia [Time frame: 2 years]
Secondary outcome measures (2)
- Maternal blood concentration of fetal anesthesia [Time frame: 2 years]
- Fetal blood concentration of maternal anesthesia [Time frame: 2 years]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-only
Study locations
United States · 1 center
- Boston Children's Hospital — Boston
Identifiers
NCT: NCT07571811 · IRB-P00051770