Boston Children's Hospital
Boston, Massachusetts, 02115, United States
Not Yet Recruiting
NCT Number: NCT07571811
Pharmacokinetic and Pharmacodynamic Investigations of Fetal Anesthesia During Maternal Fetal Surgery
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.
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Conditions
Age range
13 year and older
Sex eligibility
Female
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
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Maximum plasma concentration (Cmax) of fetal anesthesia
Time frame: 2 years
Characterize the plasma concentrations / pharmacokinetics profile, specifically the peak plasma concentration (Cmax) of commonly used fetal anesthetics, investigate the pharmacodynamic effects of anesthetics on fetus, assess the maternal-fetal transfer of anesthetics during surgery, and identify potential variations during different stages of fetal development.
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Area under the plasma concentration versus time curve (AUC) of fetal anesthesia
Time frame: 2 years
Characterize the plasma concentrations / pharmacokinetics profile, specifically the area under the plasma concentration versus time curve (AUC) of commonly used fetal anesthetics, investigate the pharmacodynamic effects of anesthetics on fetus, assess the maternal-fetal transfer of anesthetics during surgery, and identify potential variations during different stages of fetal development.
Secondary outcomes
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Maternal blood concentration of fetal anesthesia
Time frame: 2 years
Measure the maternal blood concentration of fetal anesthesia to characterize fetal-maternal transfer of commonly used fetal anesthetics.
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Fetal blood concentration of maternal anesthesia
Time frame: 2 years
Measure the fetal blood concentration of maternal anesthesia to characterize fetal-maternal transfer of commonly used maternal anesthetics.
Study contacts
Contact information is provided by the study sponsor or research team.
Julia Atayde, BS
CONTACT
Rachel Bernier, BS, MPH
CONTACT
Sponsors and collaborators
Lead sponsor
Boston Children's Hospital
Other
Registry information
Important dates
- Study start
- 2026
- Primary completion
- 2026
- Study completion
- 2027
- First posted
- May 6, 2026
- Registry last updated
- May 6, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.