Fetal AnesthesiaNCT07571811
Pharmacokinetic and Pharmacodynamic Investigations of Fetal Anesthesia During Maternal Fetal Surgery
An observational study of Fetal Anesthesia, run by Boston Children's Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 13 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Anesthesia
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2026to 1 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Pregnant women undergoing maternal-fetal surgery
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
Gwen Owens, MD, PhD, 515-720-3908, gwen.owens@childrens.harvard.edu
About this study
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women undergoing maternal-fetal surgery | Pregnant women undergoing maternal-fetal surgery requiring fetal anesthesia. This study is purely observational. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 years
Secondary outcomes (2)
Maternal blood concentration of fetal anesthesia
Measure the maternal blood concentration of fetal anesthesia to characterize fetal-maternal transfer of commonly used fetal anesthetics.
Measured: 2 years
Fetal blood concentration of maternal anesthesia
Measure the fetal blood concentration of maternal anesthesia to characterize fetal-maternal transfer of commonly used maternal anesthetics.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start1 May 2026 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal AnesthesiaStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gwen Owens, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07571811
- Sponsor's protocol ID
- IRB-P00051770
- Status last verified
- Apr 2026
- First submitted
- 20 Apr 2026
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic and Pharmacodynamic Investigations of Fetal Anesthesia During Maternal Fetal Surgery
- ClinicalTrials.gov ID
- NCT07571811
- Acronym / sponsor ID
- IRB-P00051770
- Conditions
- Fetal Anesthesia
- Keywords
- fetal anesthesia, fetal, intrauterine, fetal cardiac intervention, iut, intrauterine transfusion
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women undergoing maternal-fetal surgery | – | –Pregnant women undergoing maternal-fetal surgery requiring fetal anesthesia. This study is purely observational. |
Who may qualify
- Ages
- 13 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant women undergoing maternal-fetal surgery
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
2 secondary outcomes
Maternal blood concentration of fetal anesthesia
Time frame: 2 years
Fetal blood concentration of maternal anesthesia
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Anesthesia, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julia Atayde, BS (617-355-2967, julia.atayde@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum plasma concentration (Cmax) of fetal anesthesia (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.