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Pharmacokinetic and Pharmacodynamic Investigations of Fetal Anesthesia During Maternal Fetal Surgery

30. april 2026 opdateret af: Gwen Owens, Boston Children's Hospital

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Fetal Anesthesia

Undersøgelsestype

Observationel

Tilmelding (Anslået)

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Navn: Rachel Bernier, BS, MPH
Telefonnummer: 857-218-5348
E-mail: rachel.bernier@childrens.harvard.edu

Undersøgelse Kontakt Backup

Navn: Julia Atayde, BS
Telefonnummer: 617-355-2967
E-mail: julia.atayde@childrens.harvard.edu

Studiesteder

Forenede Stater
- Massachusetts
  - Boston, Massachusetts, Forenede Stater, 02115
    - Boston Children's Hospital
    - Kontakt:
      
      Gwen Owens, MD, PhD
      
      Telefonnummer: 515-720-3908
      
      E-mail: gwen.owens@childrens.harvard.edu

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

Barn
Voksen
Ældre voksen

Tager imod sunde frivillige

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Pregnant women undergoing maternal-fetal surgery

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal grupper/kohorter

Kohorter og interventioner

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Maximum plasma concentration (Cmax) of fetal anesthesia Tidsramme: 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.	2 years
Area under the plasma concentration versus time curve (AUC) of fetal anesthesia Tidsramme: 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.	2 years

Sekundære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Maternal blood concentration of fetal anesthesia Tidsramme: 2 years	Measure the maternal blood concentration of fetal anesthesia to characterize fetal-maternal transfer of commonly used fetal anesthetics.	2 years
Fetal blood concentration of maternal anesthesia Tidsramme: 2 years	Measure the fetal blood concentration of maternal anesthesia to characterize fetal-maternal transfer of commonly used maternal anesthetics.	2 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Boston Children's Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. maj 2026

Primær færdiggørelse (Anslået)

1. maj 2026

Studieafslutning (Anslået)

1. maj 2027

Datoer for studieregistrering

Først indsendt

20. april 2026

Først indsendt, der opfyldte QC-kriterier

30. april 2026

Først opslået (Faktiske)

6. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)