Pharmacokinetic and Pharmacodynamic Investigations of Fetal Anesthesia During Maternal Fetal Surgery

NCT07571811 | Not Yet Recruiting

• 1 other identifier: IRB-P00051770
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fetal Anesthesia

Keywords

fetal anesthesia; fetal; intrauterine; fetal cardiac intervention; iut; intrauterine transfusion

Outcome Measures

Primary Outcomes (2)

• Maximum plasma concentration (Cmax) of fetal anesthesia

  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.

  2 years

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

  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.

  2 years

Secondary Outcomes (2)

• Maternal blood concentration of fetal anesthesia

  2 years

• Fetal blood concentration of maternal anesthesia

  2 years

Study Arms (1)

Pregnant women undergoing maternal-fetal surgery

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

Eligibility Criteria

• Age: 13 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women undergoing maternal-fetal surgery

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.

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Retained samples will consist of small-volume discarded fetal blood specimens (approximately 100-250 µL per sample) collected during clinically indicated fetal procedures that would otherwise be discarded. For participants who separately consent to the optional component, retained samples may also include maternal peripheral blood specimens collected at time points matched to fetal sampling.

Central Study Contacts

Julia Atayde, BS

CONTACT

617-355-2967; julia.atayde@childrens.harvard.edu

Rachel Bernier, BS, MPH

CONTACT

857-218-5348; rachel.bernier@childrens.harvard.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor of Anesthesia, Harvard Medical School

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: May 6, 2026
• Study Start: May 1, 2026
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)