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Understanding Fetal Anesthesia During Maternal-Fetal Surgery

This study is looking at how three common medications—fentanyl, rocuronium, and atropine—work in a fetus during maternal-fetal surgery. Researchers want to understand how these drugs are absorbed, distributed, and cleared from the body (pharmacokinetics), and how they affect the fetus (pharmacodynamics). They also want to see how these drugs move from the mother to the fetus through the placenta. The study will measure drug levels in blood samples already being collected for routine fetal care. You may be able to join if you are pregnant, undergoing maternal-fetal surgery that requires fetal anesthesia, and your fetus needs blood sampling as part of their usual care. This study aims to enroll 10 participants, but its current status is unclear.

Study design
This is an observational study, meaning researchers will gather information without giving any new treatments. It plans to include 10 pregnant women.
What's involved
The study will use blood samples already collected as part of your fetus's usual care. There is an optional maternal blood draw.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints, measuring drug concentrations, are assessed at 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07571811

Pharmacokinetic and Pharmacodynamic Investigations of Fetal Anesthesia During Maternal Fetal Surgery

Not Yet Recruiting
Not specifiedAges 13+Observational
Boston Children's Hospital
~10 participants
Updated 2026-05-06 on ClinicalTrials.gov

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum plasma concentration (Cmax) of fetal anesthesia
Measured over 2 years
+1 more outcome measured

Conditions

Fetal Anesthesia

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NCT07571811

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Boston Children's Hospital

    Boston, Massachusettsstudy coordinator listed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Julia Atayde, BS
[email protected]
617-355-2967
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Maximum plasma concentration (Cmax) of fetal anesthesia2 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.

  • Area under the plasma concentration versus time curve (AUC) of fetal anesthesia2 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.